Member States of the WHO South-East Asia (SEA) Region have prioritized attention to research in traditional medicine and supported substantial research activity to promote evidence-based traditional medicine practices. Many research reports have been published in national and international journals. However, despite many such research studies in countries, these have not been analysed systematically in terms of topic, area of research, and issues, challenges and gaps. On account of this, research findings are inadequately reflected in policy guidance on the development of traditional medicine and its appropriate integration with the public health care delivery systems. This publication provides a detailed account of traditional medicine research status in Sri Lanka during 2014–2019 with reference to research activities, types of clinical research, main health conditions studied, and the gaps, issues and challenges relating to clinical research in traditional medicine. It also enumerates the existing principles and practices for conducting research, including code of conduct, ethics, monitoring and evaluation, regulatory systems, reporting and dissemination, legal frameworks for protecting intellectual property rights, and administrative procedures. A review of in Sri Lanka: 2015–2019 traditional medicine research 9 7 8 9 2 9 0 2 2 8 9 8 1 ISBN 978-92-9022-898-1 A review of traditional medicine research in Sri Lanka: 2015–2019 A review of traditional medicine research in Sri Lanka: 2015–2019 ISBN: 978-92-9022-898-1 © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY- NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. 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The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Printed in India iiiA review of traditional medicine research in Sri Lanka: 2015–2019 Contents Acknowledgements .......................................................................................................................v Abbreviations ............................................................................................................................... vi Message of the Regional Director ................................................................................................ vii Preface ........................................................................................................................................viii Executive summary ........................................................................................................................x 1. Overview ..............................................................................................................................1 1.1 Background .......................................................................................................................1 2. Conducting Traditional Medicine Research in Sri Lanka – Governance and Ethics .................3 2.1 Ethical framework of research on herbal medicine .............................................................3 2.2 Code of Conduct for Health Research in Sri Lanka .............................................................5 2.3 Sri Lanka Clinical Trial Registry ...........................................................................................9 2.4 Ethics review committees in Sri Lanka ..............................................................................10 2.5 International and national clinical research guidelines and reports ...................................11 2.6 Main institutions in Sri Lanka involved in TM research and development, policy-making and grants .................................................................................................12 3. A Scoping Review of Traditional medicine research in Sri Lanka (2015–2019) ....................15 3.1 Background .....................................................................................................................15 3.2 Review methodology .......................................................................................................15 3.3 Results .............................................................................................................................18 3.4 Discussions ......................................................................................................................54 4. Research gaps and challenges – The way forward for TM research in Sri Lanka ..................58 4.1 Introduction ....................................................................................................................58 4.2 Safety and standardization of herbal products .................................................................58 4.3 Supporting TM research: Clinical trials, case reports, community-based studies and policies .....................................................................................................................61 4.4 Developing the TM market ..............................................................................................66 4.5 Protecting traditional medicine knowledge in Sri Lanka ...................................................67 4.6 Summary of current status and challenges of TM research and development ..................70 5. References ..........................................................................................................................74 Annexes 1. Reporting observational studies – STROBE statement (217) ................................................83 2. Template for writing a clinical trial research report .............................................................86 3. Template for writing a case report......................................................................................89 vA review of traditional medicine research in Sri Lanka: 2015–2019 Acknowledgements This review of traditional medicine research in Sri Lanka between 2015 and 2019 was undertaken by Dr. Pathirage Kamal Perera, Senior Lecturer in Ayurveda, Department of Ayurveda, Pharmacology, and Pharmaceutics, Institute of Indigenous Medicine, University of Colombo and Consultant Physician in National Ayurveda Teaching Hospital, Sri Lanka, with support from a team of the WHO Regional Office for South-East Asia led by Mr Manoj Jhalani, Director, Department of Health Systems Development, Dr Manisha Shridhar, Technical Officer for Intellectual Property Rights, and Dr Sungchol Kim, Regional Adviser for Traditional Medicine. The technical content and text were further reviewed and elaborated by Dr Suzanne Grant of the Western Sydney University, Australia. Our sincere thanks are given to Senior Professor Chandrika N. Wijeyaratne, Vice-Chancellor of the University of Colombo; Senior Professor Dr. Priyani Paranagama, Director, Institute of Indigenous Medicine, the University of Colombo for facilitating by granting leave to conduct this review to Dr.P.K. Perera. Further, we extend our thanks to all contributors for their valuable contribution. They include Dr. Swarna Kaluthota, Director at the Bandaranaike Memorial Ayurvedic Research Institute; Dr. Sunil de Alwis, Deputy Director-General, Education, Training and Research, Ministry of Health, Nutrition and Indigenous Medicine of Sri Lanka; and Dr. Nishan Jayasundara (NJ) and Dr Hallinnage Gihani (HG), both research assistants, Institute of Indigenous Medicine, University of Colombo; and heads and library staff of the Institute of Indigenous Medicine, University of Colombo. vi A review of traditional medicine research in Sri Lanka: 2015–2019 Abbreviations CAM complementary and alternative medicine CCHRS Code of Conduct for Health Research in Sri Lanka CENTRAL Cochrane-controlled trials register CKD chronic kidney disease CMC chemical-manufacturing-control CONSORT consolidated standards of reporting trials DoH Department of Health DSMB Data Safety Monitoring Board EBM evidence-based medicine EFGCP European Forum for Good Clinical Practice ERC Ethics Review Committee EU European Union FERCSL Forum for Ethics Review Committees in Sri Lanka ICH International Conference on Harmonization WHO ICPC WHO International Classification of Primary Care ICTRP International Clinical Trials Registry Platform NIPO National Intellectual Property Office RCR randomized controlled research RCTs randomized control trials SIDCER Strategic Initiative for Developing Capacity in Ethical Review TM traditional medicine T&CM traditional and complementary medicine viiA review of traditional medicine research in Sri Lanka: 2015–2019 Message of the Regional Director Many Member States of the WHO South-East Asia Region have a long history of traditional medicine. In almost all countries of the Region, traditional medicine is part of health-care delivery services, potentially contributing towards the achievement of universal health coverage and the WHO Thirteenth General Programme of Work. Traditional medicine knowledge is valuable only if it works. Research in TRM and its proper practice can play a vital role in its acceptance. The core function of WHO is to support Member States in strengthening national research capacity towards evidence-based medicine. The WHO Regional Office for South-East Asia has made strengthening national research capacity in traditional medicine a top priority of the regional traditional medicine programme, in line with the WHO Global Traditional Medicine Strategy 2014 –2023, as well as the Delhi Declaration on Traditional Medicine, adopted at the International Conference on Traditional Medicine in February 2013. Sri Lanka is one of several Member States of our Region with a long history of use of traditional medicine, providing a compelling case study. Through this review on current research activities in traditional medicine in Sri Lanka, all readers – including traditional medicine researchers – will gain an understanding of the overall situation of research in Sri Lanka, including an insight into the total number of research activities in the defined time period, the different types of research conducted, the various health conditions studied, and the key challenges and issues to be overcome for improving the quality of traditional medicine research. Long-term development of traditional medicine will help harmonize and appropriately integrate it into health-care delivery services currently dominated by allopathic medicine. In the evolution of allopathic and traditional medicine, the quest for evidence, quality and safety continues. This publication is a contribution to that effort. Dr Poonam Khetrapal Singh Regional Director WHO South-East Asia Region viii A review of traditional medicine research in Sri Lanka: 2015–2019 Preface It gives me great pleasure to know that a country case study on research in traditional medicine has been done in the WHO South-East Asia (SEA) Region. It is the first such study of its kind. Use of traditional medicine has expanded and gained popularity globally not only in low- and middle-income countries but also in high-income countries where conventional medicine is predominant in the national health-care system. Given such a global expansion in the use of traditional medicine, the safety, efficacy and quality of traditional medicines have become important concerns for both health authorities and the public. Thus, one of the goals of the WHO Traditional Medicine Strategy 2014–2023 and of action points of the Delhi Declaration on Traditional Medicine adopted in 2013, is to promote safe and effective use of traditional medicine through research and regulation. The WHO Regional Office for South-East Asia has identified capacity-building in traditional medicine research as one of the regional priority areas. Given the increasing demand for evidence-based traditional medicine and its global popularity, some Member States of the WHO SEA Region have paid attention to research in traditional medicine and have supported substantial research activities. Many of the research reports have been published in the national and international journals. Despite the fact that several research studies have been done in various countries, these have not yet been analysed systematically in terms of topics, areas of research, issues and challenges, and the gaps that require to be researched. Therefore, it has resulted in insufficient reflection of the research findings on policy guidance and directions towards development of traditional medicine, and appropriate integration of traditional medicine in the public health-care delivery system. In order to facilitate Member States of the WHO SEA Region to undertake such analytical activities and processes, the Regional Office initiated country studies on traditional medicine research status and the existing principles and practices for conducting research, such as code of conduct, ethical framework, monitoring and evaluation, regulatory system, reporting and dissemination, legal framework for protecting intellectual property rights, administrative procedures and process. Sri Lanka is one of the Member States with a rich heritage and long history of use of traditional medicine. The Government has strongly supported the development of the traditional system of medicine for a long time and the country had an independent Ministry of Indigenous Medicine till 2014. This project analyses the current research status in traditional medicine for the period of 2014–2019 in terms of research activities, types of clinical research, main health conditions studied, main gaps, issues and challenges relating to clinical research in traditional medicine. ixA review of traditional medicine research in Sri Lanka: 2015–2019 However, it was inevitable that the project would have its limitations due to a constrained budget, time and capacity for analysis. Nevertheless, we hope that the findings of this study would add value to our research endeavours in traditional medicine and facilitate policy-makers in framing appropriate and effective policies, and making evidence-based decisions. It would help also researchers in identifying research topics and improving their quality of research in traditional medicine. We welcome any observations and comments on the country study report. Dr Kim Sungchol Regional Adviser for Traditional Medicine Department of Health Systems Development WHO South-East Asia Region x A review of traditional medicine research in Sri Lanka: 2015–2019 Executive summary Preamble In 2014, the World Health Organization endorsed the WHO Traditional Medicine (TRM) Strategy 2014–2023 (1) with the goals of harnessing the potential contribution of TRM to ensuring health, wellness and people-centred health; promoting safe and effective use of TRM; and achieving universal health coverage (UHC) by regulating TRM products, practices and practitioners. In 2014, the WHO Regional Office for South-East Asia (WHO-SEARO) adopted a regional resolution on traditional medicine, wherein all Member States agreed to adopt and implement the WHO TRM Strategy 2014–2023 and the Delhi Declaration on TRM (2). To assist and support Member States in implementing these strategies, WHO-SEARO organized a regional workshop on TRM and identified the regional TRM action points in 2015 (3). The workshop aimed to strengthen research capacity in traditional medicine through training and documentation of research activities. As per this action point, the WHO-SEARO TRM programme is conducting a number of activities, including regional workshops on clinical research methodologies. Given the increasing demand for evidence-based traditional medicine, many Member States in the SEA Region have invested time and resources in TM research. Research output is evident in domestic and international journals and publications. Sri Lanka was the only country in the world with an independent Ministry of Indigenous Medicine before 2015 (later it was integrated with the Ministry of Health, Nutrition and Indigenous Medicine). The Sri Lankan government has provided substantial support for research and development (R&D) in traditional medicine. However, the outcomes of the research effort are not widely known and have not been disseminated to the public in many cases. Therefore, this country review was planned to better understand the scope of research in traditional medicine in terms of key achievements, gaps, challenges and roadmap for R&D in traditional medicine. The research activity may further nourish and support future activities in other Member States. Key message A lack of rigorous clinical trials was found to be the major drawback in TM research being undertaken in Sri Lanka. While the quality of the clinical trials was not the focus of this review, most studies were published only in conference proceedings and few in peer-reviewed journals, and even fewer in journals with high citation indexes. Many of the randomized controlled trials (RCTs) did not adequately report on key study components such as sample selection methods, selection of outcome measures, statistical analysis and data collection methods. Most studies were at a high risk of bias. The use of relevant Ayurvedic or TM outcome measures was also absent in some clinical trials. xiA review of traditional medicine research in Sri Lanka: 2015–2019 Case studies and case series dominate the research being carried out in Sri Lanka. The quality of these lacked uniformity and can be improved by adhering to a case study-reporting format such as that suggested in this review. The implementation of proper guidelines and training for TM research in Sri Lanka would help in developing the potential of TM and contribute to better use of valuable resources. The framework for conducting TM research in Sri Lanka is fairly well-established. There is a quality ethics review process for all TM health research, with a dedicated TM Ethics Review Committee (ERC) – the ERC/Institute of Indigenous Medicine (ERCIIM). Most institutional ethics committees are recognized by the WHO Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) network. However, ethics review committees for indigenous medicine need to be strengthened by recognized affiliations such as SIDCER. Many TM research institutes have established ethics review committees, but more are needed. To improve research quality, TM health researchers should be trained in and encouraged to follow good clinical practice (GCP) training, and clinical trials should be registered with the Sri Lankan Clinical Trial Registry (SLCTR) or the clinical trial registires that are accepted by WHO. A major obstacle is that clinical trial protocols reviewed by TM-based institutional ethics review committees are still not accepted by SLCTR (for example, Ethics Review Committee, Institute of Indigenous Medicine (ERCIIM)). A separate clinical trial registry for TM systems for Sri Lanka may be a solution to this. Undertaking this review highlighted difficulties in being able to comprehensively locate all TM research that has been undertaken in Sri Lanka. Much of the review required hand searching or investigating specialized e-repositories (grey literature search). The establishment of a digitalized library (in a manner that protects intellectual property) would greatly recognize the value and assist in the use of TM research findings. Most of the TM health research reviewed was carried out by university-based institutes. There is a need to build the capacity of TM research institutes such as Bandaranayake Memorial Ayurvedic Research Institute (BMARI) to promote high-quality, national-level research. The World Health Organization may act as a trusted technical mediator to improve the technical capacity of TM research in Sri Lanka. WHO may help in developing research capacity by providing research training programmes with the support of local and international experts. Furthermore, WHO can support documenting the local knowledge of TM, improving health information systems and developing policies and strategies to provide greater care to people. Recommendations Recommendations for developing TM research in Sri Lanka that have emerged from this review include: (1) supporting multidisciplinary research projects with official collaborations across institutions to build impact; (2) encouraging private-public partnership (perhaps with MoUs) to facilitate national-level research on key diseases and key TM interventions; (3) improving the current standards of research project review boards, research committees and ethics review committees at major research institutes, e.g. BMARI; xii A review of traditional medicine research in Sri Lanka: 2015–2019 (4) considering the research capacity and requirements when planning a national TM research strategy; (5) developing international collaborations through researcher training and through WHO collaborative centres; (6) encouraging all TM researchers to adhere to accepted quality standards when conducting research, e.g. GCP; (7) collaborating across all universities/institutes to promote best practices in developing TM research culture; (8) facilitating dissemination of research findings and TM research impact through publications in indexed journals; (9) improving publications and reporting, encouraging the use of internationally recognized standards for observational studies, including case studies and case series (4); and (10) establishing a traditional medicine- and traditional knowledge-specific registration and innovation patent system. This will be aided by the implementation of the proposed Act, called The protection of traditional knowledge in Sri Lanka, drafted in 2009, with further amendments by stakeholders involved in TM in Sri Lanka. 1A review of traditional medicine research in Sri Lanka: 2015–2019 1 Overview 1.1 Background Traditional medicine (TM) continues to be used by almost 50% of the population in countries such as the United States of America (42%) and Australia (48%), with higher use reported in many developing countries (5). In India, Ayurvedic medicine is used by an estimated 59% (6) of the population. In Japan, around 70% of physicians prescribe Kampo medicines in daily practice (7). Unani medicine is still used by a vast majority of people in West Asia and South Asia. An estimated 80% of the population in developing countries depend on traditional systems of medicine as a source of primary health care (8). In Sri Lanka, an estimated 75% of the population use traditional medicine. In rural areas, traditional systems of medicine cater to 60–70% of the population’s primary health care needs (9,10). There are around 20 353 registered Ayurvedic physicians and an additional 8000 traditional practitioners in the country. Over the past decade, herbal medicine and related products have become a topic of increasing global importance, having repercussions for both world health and international trade. Recognition of medical and economic benefits of plant-based medicines is growing in both developing and industrialized countries, although it varies greatly from country to country (11). Although difficult to calculate with accuracy, the total global market for herbal medicine was estimated to be US$ 83 billion in 2019 and is expected to reach US$ 411.2 billion by 2026 and US$ 550 billion by 2030 with a compound annual growth rate (CAGR) of 18.9% through 2030 (12,13). Currently, governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Along with herbal medicine, other herbal products such as cosmetics, fragrances, tea, health foods and nutraceuticals are equally popular and constitute a large proportion of the global herbal business (14). Sri Lanka is blessed with at least four extant systems that use herbal products in a variety of ways in clinical practice: Ayurveda, rich and uniquely native Desheeya Chikitsa, Siddha and Unani. Ayurveda and the indigenous system of medicine, Desheeya Chikitsa, have been practised in Sri Lanka for more than 3000 years. According to the Sri Lanka Ayurveda Act (No. 31 of 1961), “Ayurveda” includes all the traditional medical systems, namely Siddha, Unani and Desheeya Chikitsa, the latter being the earliest system of medicine existing in Sri Lanka before the advent of Ayurveda (15). Ayurveda forms a part of the National Health Services, provided by the Government of Sri Lanka, and includes a separate ministry for indigenous medicine. The government’s health planning blueprint recognizes the importance of Ayurveda and its workforce, particularly in preventative medicine (16). 2 A review of traditional medicine research in Sri Lanka: 2015–2019 In Sri Lanka, there were 19 754 Ayurvedic physicians registered under the Sri Lanka Ayurveda Medical Council in 2010. Among those registered, general practitioners of Ayurveda accounted for 84.9% of registrations, Siddha 12.7% and Unani 2.7%. Specialist physicians were primarily Ayurvedic practitioners (96.5%). Apart from these registered physicians with the Ayurveda Medical Council, there are more than 8000 traditional medical practitioners, who are descendants of reputed families with secret formulae to cure diseases, engaged in public health care. Research in Sri Lanka on TM is supported by a strong basic science sector. However, this is not matched by quality clinical trials. The trends, quality and outcomes of clinical studies are not widely known and are not routinely shared with the public. This review was undertaken to: (1) provide an understanding of the context of TM research in Sri Lanka; (2) explore the breadth of the literature, map and summarize the evidence, and inform future research on TM in Sri Lanka through a scoping study; and (3) outline challenges in research and development on traditional medicine in Sri Lanka. 3A review of traditional medicine research in Sri Lanka: 2015–2019 2 Conducting Traditional Medicine Research in Sri Lanka – Governance and Ethics This chapter outlines the research context for traditional medicine research in Sri Lanka. The main organizations and key guidelines involved in research governance of traditional medicine in Sri Lanka are: (1) Ethical Framework for Traditional Medicine Research (2) Code of Conduct for Health Research in Sri Lanka (CCHRS) (3) Sri Lanka Clinical Trials Registry (SLCTR) (4) Ethics committees in Sri Lanka for TM research (5) International and national clinical research guidelines & reports (6) Main institutions in Sri Lanka involved in TM research and development, policy-making and grants. 2.1 Ethical framework of research on herbal medicine In Sri Lanka, research on traditional systems of medicines is subject to the same ethical requirements as all research related to human subjects in the allopathic system of medicine. Traditional medicine research should follow the Code of Conduct for Health Research in Sri Lanka (CCHRS, see Section 2.2), receive ethics approval from an appropriate ethics review committee (see Section 2.4) and, where appropriate, be registered with SLCTR (see Section 2.3). The research should also abide by laws and regulations in the country and good clinical practice (GCP) (Fig. 1). An ethical framework, previously outlined by Emanuel et al. and revised for international research, offers a useful starting point for thinking about the ethics concerning traditional systems of medicine research (17). This framework includes eight ethical requirements for clinical research (Table 1). These ethical requirements are universal and comprehensive, but should be adapted to the particular social context in which the research is implemented (18). The Sri Lankan ethical framework is also based on these principles. 4 A review of traditional medicine research in Sri Lanka: 2015–2019 Fig. 1. Protocol development[based on the course material of the diploma course in research and development of products to meet public health needs (2013), Nagasaki University, Japan] ‘Protocol should contain a statement of the ethical considerations involved and should indicate how the principles in DoH have been addressed’ Declaration of Helsinki 20138 Article 22 The Protocol GCP Study protocol Table 1. A comprehensive framework for research ethics Collaborative partnership Research leadership must include bilateral representation based on mutual respect between equal partners with community advice. It includes a responsibility to invest in scientific training and capacity-building for ongoing research in a host country where such resources are not developed Social value Knowledge gained from the research should have the potential to lead to new generalizable knowledge or improvements in health. Partners should specify in advance to whom benefits will accrue and in what way. Scientific validity Research should be designed to produce beneficial and generalizable knowledge. This includes designing research so that it can be feasibly implemented in the settings where it will be conducted. Fair subject selection Subjects should be selected on the basis of scientific importance, not based on convenience, vulnerability or bias. Favourable risk– benefit ratio The potential benefits of individual participation should outweigh the risks of participation. Benefits to the community or population being studied should also be optimized. Compelling societal benefit can justify risks to individuals in certain circumstances. Independent review To maintain the integrity of the research, bodies not tied to the investigators must agree that the risks and potential benefits of the research are justified. Informed consent Investigators must obtain valid permission for study participation from subjects in a manner that is sensitive to the cultural context in which the study is conducted. Respect for subjects Researchers should have a plan for how the research results will be disseminated, ensuring that participants know their right to withdraw and monitoring the research for relevant adverse events. (Source: Tilburt JC, Kaptchuk TJ (2008) Herbal medicine research and global health: An ethical analysis. Bull World Health Organ 66: 594–599) 5A review of traditional medicine research in Sri Lanka: 2015–2019 2.2 Code of Conduct for Health Research in Sri Lanka The Code of Conduct for Health Research in Sri Lanka applies to all medicine research undertaken in the country (19). CCHRS was developed in 2018 by the education, training and research unit within the National Health Research Council in Sri Lanka under the Ministry of Health. Technical assistance to develop this code was provided by Monash University, Melbourne, Australia. Prior to the development of CCHRS, responsible conduct of research was guided by a multitude of existing non-binding guidelines, regulations and declared policies of individual research institutions. CCHRS is a comprehensive national document that fulfils a long-standing gap in the health- and health-related research community of Sri Lanka. The CCHRS provides a set of duties and responsibilities for institutions and researchers to follow in order to promote integrity of health- and health-related research. All health research institutes and researchers adhere to this code in Sri Lanka. We have provided a brief overview of the requirements of CCHRS and how it applies to TM research in Sri Lanka. 2.2.1 Development of a research protocol The CCHRS defines research protocol as a summary document of a research plan that outlines the topic, research question, aims and objectives, study design and methods, plan for data analysis, sources of funds and timeline. A research protocol also details the steps taken to address ethics issues in the conduct of the research. Key institutional and researcher’s responsibilities related to formulation of research protocols (Fig. 1) are detailed in CCHRS. To date, in TM research in Sri Lanka, there is no direct process to register protocols for interventional studies, cohort studies and registries at the national level. Protocols may be registered with the International Prospective Register of Systematic Reviews (PROSPERO). 6 A review of traditional medicine research in Sri Lanka: 2015–2019 Fig. 2. Traditional medicine research protocol formulation in Sri Lanka (CCHRS) Formulation of research protocols Institutional responsibilites Provide published guidelines, procedures and policies Publicize national and institutional research priorities Advertise and award research grants Ensure that the proposals are submitted by researchers/teams with relevant expertise/qualifications Ensure transparent peer review mechanism for proposal evaluation, including ethics Researcher's responsibilities Adhere to the guidelines, procedures and policies of the institution Obtain ethics clearance for the protocol and for any subsequent modifications and any other authorization, permission and clearances Register protocols for interventional studies, cohort studies and registries at the national level 2.2.2 Conduct of research Research should be conducted honestly, accurately, objectively and efficiently to ensure its integrity. This will result in high-quality, safe, ethical, generalizable and reproducible research that leads to meaningful improvements in health and well-being. Poor-quality research entails an unfortunate waste of time, effort and valuable resources. CCHRS recommends that institutions and researchers responsible ensure high-quality research that is conducted with integrity. Researchers should have the necessary qualifications and competence to conduct research. The scientific integrity and credibility of a study depend substantially on the study design and methodology. The research protocol should meet the application requirements of an ethics review committee (20). TM researchers should ensure that they address all comments provided during the ethics review process. When conducting traditional medicine-based health research, it is suggested that at least one of the researchers should be an Ayurvedic, Unani or Siddha medical doctor registered under the Sri Lanka Ayurveda Medical Council. In the event that the health research is a collaboration with the allopathic medicine system, the research team should include a medical doctor registered with the Sri Lanka Medical Council. According to the ERC guidelines, when conducting clinical research, investigators should be proficient in good research practices, including good clinical practice and good laboratory practice (GLP), where relevant, as well as trained in statistical analysis, data interpretation and research ethics. 7A review of traditional medicine research in Sri Lanka: 2015–2019 Data should be collected and recorded meticulously. Primary materials should be stored appropriately and retained for inspection for a specific period of time. In general, the minimum recommended period for retention of research data spans five years from the date of publication, but varies, based on the type of research, such as: clinical trials – minimum 15 years; cohort studies – retained permanently; gene therapy – clinical records retained permanently; and where research has community or heritage value – retained permanently. If a research project includes more than one type of research, a longer period of retention is applied. 2.2.3 Monitoring and evaluation of research Research project evaluation is mainly carried out by higher degree committees at the university level and boards of research at national-level institutes in an unbiased manner, with a blind peer review process. Furthermore, health research projects are evaluated and monitored by institutional ethics review committees through independent review process. Ethics review committees evaluate both the ethics and scientific backgrounds of each project. Monitoring of research is undertaken by an individual ERC that has granted ethics clearance. The ERC monitors approved research studies to ensure compliance. The ERC may request, at any time, information on any relevant aspects of the study and discuss any issue of relevance with the researchers. The principal investigator is required to provide progress reports, at least annually, and a final report following the conclusion of the study. In the case of clinical trials, quarterly reports are required, which are reviewed by the ERC in the first instance. Extension of approval for a further period is subject to the progress reports submitted by the principal investigator as called for in the letter of approval. In determining the frequency and type of monitoring required for approved studies, the ERC considers the degree of risk to participants in the research. The ERC may adopt whatever measures it considers appropriate for monitoring. The ERC requires, as a condition of approval for each proposal, that investigators immediately report anything which might warrant review of the ethical approval of the protocol. The ERC requires, as a condition of approval for each proposal, that investigators inform the ERC, providing reasons, if the research study has been discontinued before the expected date of completion. Should the ERC become aware, on soild grounds, of circumstances that have arisen which prevent a research study from being conducted in accordance with the approved protocol, it may withdraw approval. In such circumstances, the ERC informs the principal investigator and the institution about such withdrawal of approval in writing, and recommends to the institution that the research study be discontinued or suspended or that other necessary steps be taken (21). 8 A review of traditional medicine research in Sri Lanka: 2015–2019 2.2.4 Dissemination of research findings Health-care resources are finite. It is imperative that the delivery of high-quality health care is ensured through the successful implementation of cost-effective health technologies. However, there is growing recognition that the full potential for research evidence to improve practice in health-care settings, either in relation to clinical practice or to managerial practice and decision-making, has not yet been realized (22). Addressing deficiencies in the dissemination and transfer of research-based knowledge to routine clinical practice is high on the policy agenda both in the United Kingdom (23) and internationally. Accordingly, CCHRS encourages timely dissemination of research findings as an important part of the research process. It facilitates translating research findings into practice, guiding future research and passing on the benefits of research to health-care services and to society. This code applies to dissemination of research findings through publications in journals as well as mass media, the Internet and other communication platforms. 2.2.5 Administrative procedures, process and approval for research After ethics approval by an ERC, investigators are required to obtain approval from the site or the institution where the research project is to be conducted. Investigators are required to negotiate individual arrangements with the heads of service departments in those institutions, where the use of their resources is involved. Institutions involved in research projects should ensure that an agreement is reached among the researchers. The agreement should be in writing. It must cover confidentiality, copyright issues, intellectual property rights, storage and sharing of generated data, sharing commercial returns, responsibility for ethics and safety clearances and reporting to appropriate agencies. Furthermore, it is necessary to specify the ownership of data of collaborative research in the event of a premature end or on completion of the research. 2.2.6 Research misconduct and managing allegations CCHRS considers the following behaviours or actions to be classified as research misconduct: intentional use of research findings to fulfil goals or purposes other than what is stipulated in the protocol; misconduct in relation to the collection of data; fabrication, falsification, conscious misinterpretation or misrepresentation of data, deception in proposing and carrying out and reporting the results of research; plagiarism, misleading ascription of authorship, including listing of authors without their permission, inappropriate omission of authors and including as authors those who have not contributed to the research, and lack of appropriate acknowledgment of the work of others; failure to declare or manage any conflict of interest; unauthorized deviation from the research protocol approved by an ethics review committee; willful support, assistance, concealment or facilitation of research misconduct by others; 9A review of traditional medicine research in Sri Lanka: 2015–2019 failure to provide adequate guidance or mentorship for researchers or trainees under supervision; and inappropriate utilization of funds by researchers, including not conforming to the policies of the funding agency. Institutions are responsible for managing allegations of research that has not been conducted responsibly. It is required that misconduct or breaches be identified, investigated and managed. 2.2.7 Managing conflict of interest Avoid and minimize conflict: Although it is not possible to avoid all sources of conflict, it is in the best interests of the scientific community and individual scientists to recognize conflicts of interest and to take steps to nullify or mitigate those conflicts. Disclose interests: If conflicts cannot be avoided, then those conflicts should be disclosed. At least, the institution and any other parties with a significant interest should be made aware of the extent and nature of the conflict. Manage conflicts: Disclosure is often not enough. For every step of the research process, attempts should be made to isolate the conflicted individuals from all decision-making functions. Keep learning: Both the potential for conflicts of interest and the strategies for dealing with those conflicts are evolving. Considering the potential for misperceptions of a researcher’s motives, it is best to assume that good intentions are not enough. Seek information so as to comply with the spirit and letter of current regulations (24). 2.2.8 Legal framework and regulation mechanism The Sri Lankan policy on indigenous medical systems has been drafted but not yet finalized. There is no clinical research Act established for traditional systems of medicine in Sri Lanka. Subsequently, all indigenous medical system research is regulated by individual research authorities within universities and research institutes such as BMARI. 2.2.9 Financial regulations All research institutes adhere to institutional financial policies and regulations and are responsible for internal audit systems of their own institutes and also responsible for national auditing. Researchers should strictly adhere to financial regulations stipulated by the funding agencies and institutional financial grants should be handled through the institutional accountant. 2.3 Sri Lanka Clinical Trial Registry SLCTR (25) provides a facility for registration of trials involving human participants, conducted in Sri Lanka or overseas. SLCTR is a primary registry linked to the WHO Registry Network of the International Clinical Trials Registry Platform (WHO-ICTRP) (26). SLCTR was established by the Sri Lanka Medical Association (SLMA). It may also help promote collaborative research between Sri Lankan and foreign researchers. Some traditional medicine clinical trials are registered with SLCTR, following approval by an accredited ethics review committee. ERC accreditation is provided by the Subcommittee 10 A review of traditional medicine research in Sri Lanka: 2015–2019 on Clinical Trials (SCOCT) of the National Medicinal Regulatory Authority of the Ministry of Health, Sri Lanka (27). 2.4 Ethics review committees in Sri Lanka Ethics approval should be obtained for all TM research conducted through an ERC registered with the National Health Research Ethics Committee or Forum for Ethics Review Committees in Sri Lanka (28). Depending on the study protocol, ethics clearance for TM can be obtained from the following ERCs in Sri Lanka: ERC/Institute of Indigenous Medicine ERC/Gampaha Wickramarachchi Ayurveda Institute ERC/Faculty of Medicine – Colombo ERC/Faculty of Medical Sciences – Sri Jayawardenepura ERC/Faculty of Medicine – Jaffna ERC/Faculty of Medicine – Kotelawala Defence University ERC/Faculty of Medicine – Kelaniya ERC/Faculty of Medicine – Peradeniya ERC/Faculty of Medicine and Allied Sciences – Rajarata ERC/Faculty of Applied Sciences – Rajarata ERC/Faculty of Graduate Studies, University of Colombo ERC/Faculty of Medicine – Ruhuna ERC/Faculty of Dental Sciences – Peradeniya ERC/Faculty of Medicine – Eastern University. Most of the ERCs are recognized by the WHO Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) network (29). 2.4.1 Ethics Review Committee of the Institute of Indigenous Medicine (ERC/Institute of Indigenous Medicine) ERC/Institute of Indigenous Medicine (ERCIIM) is one of the oldest and main ERCs engaged with the ethical clearance process for the traditional systems of medicine in Sri Lanka since 2011 (20). The postgraduate section of the Institute of Indigenous Medicine, University of Colombo, established ERCIIM in 2011 to approve the research projects in indigenous/Ayurveda/traditional systems of medicine to ensure the validity and quality of research. Various professionals in Ayurveda, indigenous and scientific sectors have to meet the same level of rigor as all researchers. Obtaining ethics clearance and approval from the ERC regulates existing TM research and encourages candidates, who intend to engage in research activities in the field of traditional systems of medicine in Sri Lanka, to meet high standards. ERCIIM submission process and 11A review of traditional medicine research in Sri Lanka: 2015–2019 guidelines have been formulated to ensure that biomedical research proposals, involving human participants, tissue, data and animals used in research in Ayurveda/traditional/indigenous systems of medicine in Sri Lanka, meet international standards. The objectives of the ERCIIM are to: protect the mental and physical welfare, rights, dignity and safety of human participants and animals used in research; facilitate ethical research by effective and efficient review and monitoring processes; review research in accordance with national and/or local regulations as well as with the World Health Organization’s good clinical practices guidelines; and promote evidence-based biomedical research for upgrading the Ayurveda/traditional/ indigenous and integrated systems of medicine to ensure safety and rights of research participants, researchers and the general public. ERCIIM maintains a quality review process and is affiliated with the Forum for Ethics Review Committees in Sri Lanka. It adheres to international and national ethics guidelines. In 2019, ERCIIM was accredited by the Ministry of Health, Nutrition and Indigenous Medicine in Sri Lanka. ERCIIM maintains its own trial registry. 2.5 International and national clinical research guidelines and reports The following international and national guidelines are adhered to when conducting clinical research. Table 2. Key international guidelines and reports 1964 Declaration of Helsinki (last updated in 2013) 1978 The Belmont report (USA) (30) 1995 Clinical safety data Management: Definitions & standards for expedited reporting: ICH harmonized tripartite guideline (31) 1996 ICH harmonized tripartite guideline for good clinical practices (32) 2002 International ethical guidelines for biomedical research involving human subjects (Council for International Organizations of Medical Sciences – CIOMS) 2005 ICH harmonized tripartite guidelines (updated) 2011 Standards and operational guidance for ethics review of health-related research with human participants (WHO) (33) 2013 EFGCP guidelines on medical research for and with older people in Europe Local Ethics review committee guidelines – FERCSL – 2007 (34) Guidelines for ethics review of research proposals involving animals in Sri Lanka – FERCSL – 2009 (35) 12 A review of traditional medicine research in Sri Lanka: 2015–2019 2.6 Main institutions in Sri Lanka involved in TM research and development, policy-making and grants 2.6.1 Bandaranaike Memorial Ayurvedic Research Institute The Bandaranaike Memorial Ayurvedic Research Institute (BMARI), which was established in October 1962, functions under the jurisdiction of the Ministry of Health, Nutrition and Indigenous Medicine. BMARI is the National Centre of Excellence in Medical Research related to Ayurveda, Siddha, Unani and other medicinal systems identified by the institute. BMARI has implemented a project with the main focus on four noncommunicable diseases prevalent in Sri Lanka (cardiovascular diseases, chronic kidney diseases with known and unknown etiology, cancer and diabetes) and one communicable disease (dengue). However, it is also expected to pay attention to other important fields, if and when the BMARI research committee finds it necessary to invedstigate any particular area of concern. Special attention will also be paid to endorse health research regulatory processes, collaborative links with stakeholders and health research ethics. 2.6.2 Coordinating Secretariat for Science, Technology and Innovation The Coordinating Secretariat for Science, Technology and Innovation (COSTI) was established on 1 February2013 as mandated by a Cabinet decision of 9 September 2011 with the specific aim of coordination and monitoring of science, technology and innovation activities in the country. It is expected to work towards promoting value addition and commercialization in line with the National Science Technology and Innovation (STI) Strategy of Sri Lanka, approved by the Cabinet in August 2010. 2.6.3 Industrial Technological Institute The Industrial Technological Institute (ITI) is a wholly-owned institute of the Government of Sri Lanka that functions under the jurisdiction of the Ministry of Science, Technology and Research. It is a statutory board incorporated on 1 April 1998, under the Science and Technology Development Act No. 11 of 1994 and, as per its mandate, the objective of ITI is to elevate the level of technology in Sri Lanka to that required for rapid industrialization. ITI supports the industry by undertaking contracts on testing, investigation and research for improving product quality, technical processes and methods used in industry, and for discovering new processes and methods to be used in the industry. 2.6.4 National Science and Technology Commission The National Science and Technology Commission (NASTEC) is the apex policy-formulating and advisory body to the Government of Sri Lanka on science and technology matters. Created by an Act of Parliament, NASTEC started operating in August 1998. NASTEC is most effective in prioritizing areas of national importance with regard to science and technology and advising the government on the rational allocation of funds for research and development. Many countries such as India and China have made enormous strides in national development through timely and appropriate interventions of research and development. Realizing the important role that R&D activities can play in the development of its economy, Sri Lanka formulated a medium-term Research and Development Framework. NASTEC, working under the instructions of the Ministry of Science, Technology and Research, has been accorded the leadership role in this endeavour. 13A review of traditional medicine research in Sri Lanka: 2015–2019 Main objectives of the framework are: (1) enhancing the quality of life of the people of the country; (2) enhancing the economic development of the country; and (3) laying the foundation for Sri Lanka to become a scientifically and technologically advanced nation while preserving its environment. The formulation process commenced with the identification of focus areas that need immediate R&D interventions and appropriate interventions that may be executed with regard to the identified focus areas. The 10 focus areas identified are: (1) Water (2) Food, agriculture and nutrition (3) Health (4) Shelter (5) Environment (6) Energy (7) Mineral resources (8) Apparel industry (9) ICT and knowledge services (10) Basic sciences, emerging technologies and indigenous knowledge. Although Sri Lanka has earned a place well above the other countries in South Asia with regard to important health indicators, noncommunicable diseases (NCD) such as diabetes, cancer, ischaemic heart disease and chronic kidney diseases are on the rise. The need to address the high burden of NCD as well as control and management of vector-borne diseases and re-emerging tropical diseases such as dengue is discussed at length. Special attention has been paid to exploiting the potential of readily available indigenous knowledge and herbal resources to develop drugs through proper research and development. 2.6.5 National Health Research Council The National Health Research Council functions as an advisory body to the Education, Training and Research (ET&R) unit of the MoH to promote health research in Sri Lanka. NHRC consists of 15 members, including representatives from six medical faculties of Sri Lanka, Sri Lanka Medical Association and Post Graduate Institute of Medicine and officials from the Ministry of Health. Awarding of NHRC research grants is one of the major activities performed by the council. Research proposals submitted for funding are scrutinized for suitability by the NHRC and grants are made available for the approved proposals through the consolidated fund of the Ministry of Health. 14 A review of traditional medicine research in Sri Lanka: 2015–2019 2.6.6 National Intellectual Property Office The National Intellectual Property Office of Sri Lanka (NIPO), established under the Intellectual Property Act No. 36 of 2003, is mandated with the administration of the intellectual property system in Sri Lanka. Main functions of the NIPO include administration of intellectual property, collection and dissemination of intellectual property information and promotion of the use of intellectual property system in the development process by the intellectual property owners, enterprises and industries. 2.6.7 National Research Council The National Research Council (NRC) was established under the Ministry of Science, Technology and Research to plan and coordinate the research efforts of researchers and facilitate their research in public-sector, scientific research and development organizations in Sri Lanka so that the country can benefit from a vibrant research community. NRC has a wide range of activities that brings together academics and professionals from across the country and ensures public and private sector participation in achieving scientific advance through collaborative research. NRC is the apex body for government research funding in Sri Lanka. 2.6.8 National Science Foundation National Science Foundation (NSF), a state-funded institution under the Ministry of Science, Technology and Research, was established in 1998 by Act No. 11 of 1994 as the successor to the Natural Resources Energy & Science Authority of Sri Lanka (NARESA). The National Science Foundation is mandated to serve and strengthen the science and technology sectors in Sri Lanka and its activities conform to the National Science & Technology Policy. Accordingly, NSF facilitates research, development and innovation to create a knowledge economy. It also facilitates capacity-building, infrastructure development, technology transfer, knowledge creation and sharing in all fields of science and technology to improve the quality of life of people. 2.6.9 Postgraduate Institute of Indigenous Medicine The Postgraduate Institute of Indigenous Medicine (PGIIM) Ordinance No. 5 of 2017 was established by an order passed by the Ministry of Higher Education under Section 24A (1) of the Universities Act, No. 16 of 1978, and published in the Gazette Extraordinary No. 2031/38 of 2017. PGIIM is attached to the University of Colombo, Sri Lanka. PGIIM provides training and research in the Ayurveda, Siddha and Unani systems of medicine. 15A review of traditional medicine research in Sri Lanka: 2015–2019 3 A Scoping Review of Traditional medicine research in Sri Lanka (2015–2019) 3.1 Background Traditional medicine has the potential to play a key role in the global management of chronic diseases and preventative medicine. Lack of high-quality evidence for traditional medicine interventions is a barrier to wider utilization. However, the movement towards evidence-based medicine is not always considered congruent with the way TM systems are practised. Typically, TM diagnosis and treatment are individualized to address a patient’s unique presentation of symptoms. Nonetheless, a body of scientific evidence supporting TM is emerging in countries such as Sri Lanka. The purpose of this scoping review was to explore the breadth of TM research in Sri Lanka, map and summarize the evidence, and inform future research. A scoping review takes a broader focus than a systematic review and may include not only randomized controlled trials, but also quasi- randomized, observational studies and case reports (case studies and case series) (36). 3.2 Review methodology The objective of this scoping review was to: (1) understand the diseases or conditions that are being investigated in TM research in Sri Lanka; (2) provide insight into the types of interventions; and (3) gain an overview of study types and reporting. 3.2.1 Data sources A comprehensive search for studies conducted between January 2015 and November 2019 was undertaken. WHO commissioned this report and recommended to review the research activities carried out over the last 5 years. The following sources were searched: (a) PubMed, Cochrane-controlled Trials Register (CENTRAL) (https://www.cochranelibrary. com/), Sri Lanka Clinical Trial Registry (https://slctr.lk/), WHO International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/), the Cumulative Index to Nursing and Allied Health Literature and Web of Science were searched. 16 A review of traditional medicine research in Sri Lanka: 2015–2019 (b) Grey literature search included hand-searching the e-repositories of the universities and institutions in Sri Lanka for dissertations, theses, conference abstracts and proceedings, and key Sri Lankan journals. The institutions searched included University of Colombo, Institute of Indigenous Medicine, Gampha Wickramarachchi Ayurveda Institute, University of Peradeniya, University of Jaffna, University of Sri Jayewardenepura, Eastern University, University of Kelaniya, Sir John Kotelawala Defence University and Open University, Bandaranayke Memorial Ayurveda Research Institute and Institute of Indigenous Medicine, University of Colombo. (c) Clinical trial registries were searched. These included the Sri Lankan Clinical Trials Registry (SLCTR) and the International Standard Randomized Controlled Trial Number (ISRCTN) (https://www.isrctn.com/). An example of search strategy from PubMEDsearch is provided in Table 3. Grey literature was searched by the research team. Search results were managed in Excel. Table 3. Example search strategy – PubMed (including Medline) Search: #1 (("complementary therapies"[MeSH Major Topic] AND (humans[Filter])) OR (("medicine, ayurvedic"[MeSH Major Topic]) OR ((("herbal medicine"[MeSH Major Topic]) OR (traditional medicine[Title/Abstract])) OR (((((Ayurved*[Title/Abstract]) OR (siddha[Title/Abstract])) OR (unani[Title/Abstract])) OR (chikitsa[Title/Abstract])) OR (desheeyachikitsa[Title/Abstract]))) #2 (((("sri lanka"[Affiliation]) OR (ceylon[Affiliation])) OR (colombo[Affiliation])) OR (BMARI[Affiliation]) #3 #1 AND #2 Filters: Humans 3.2.2 Inclusion criteria Studies were included if they: (1) involved a traditional medicine intervention (Ayurveda, Unani, Siddha, Desheeya Chikitsa or other traditional medicine system); and (2) were conducted in Sri Lanka (including multicentre studies conducted in collaboration with other countries). Types of studies included were systematic reviews, randomized controlled trials, quasi- randomized, case control, case series and observational studies. We included studies if these were available as full papers published in scientific journals (available as e-copies); full paper articles published in Sri Lankan journals but not available online (retrieved as hard copies from the relevant libraries); conference abstracts (with adequate details for inclusion); and PhD, MPhil, MD and MSc academic work, in thesis or dissertation formats, available at higher education institutes in Sri Lanka (retrieved as e-repositories or from relevant university libraries). Studies were restricted to those published in English, Sinhalese and Tamil. We included studies that appeared on the registry during the scoping review window but were published after November 2019. We excluded laboratory-based studies on the molecular, chemical or pharmacological properties, in-vitro studies and animal studies. 17A review of traditional medicine research in Sri Lanka: 2015–2019 3.2.3 Screening Titles and abstracts of electronic databases were identified by KP and SG. Identified articles in grey literature were screened by KP. Full text articles were screened by KP and SG. In the case of abstracts, if enough information was included for a decision to be made using the eligibility criteria, abstracts were evaluated for inclusion. 3.2.4 Limitations This scoping review was limited by the currency of Sri Lankan e-repositories. E-repositories had not been updated continuously during the review period, and hence, some papers may not have been recorded. In some instances, theses and dissertations were not available electronically or could not be located in hard copies and could not be included in the review. Case reports were retrieved by in- person visits to key institutions. Due to the COVID-19 restrictions in 2020, we were unable to return to extract any additional data required. Many clinical research studies are not indexed to the country where they were conducted. As such, we were limited to searching according to author affiliation. 3.2.5 Data extraction Two reviewers independently screened results and selected studies. Any disagreements were resolved by consensus. A data extraction spreadsheet was used by KP and SG. Extraction was undertaken independently, results discussed and updated in an iterative process. We extracted key characteristics of studies, including study design, disease/condition, intervention, control, sample size, outcome measures and publication source. An assessment of methodological limitations or risk of bias of the evidence included within a scoping review was not undertaken as it was not relevant to the objectives of the scoping review. 3.2.6 Data presentation A descriptive approach was adopted to summarize the study characteristics. Figures were used to show the spread across Ayurveda, Siddha and Unani interventions, categories of diseases, intervention methods, control methods and outcomes, including Ayurveda-related indicators or not, research purposes and study designs. Journals were considered against the SCRImago Q ranking, which defines the rank of that journal in the specific subject field (SJR: SCImago Journal & Country Rank, http://www.scimagojr. com). For example, a Q1 journal is in the top 25% of its field and Q2 is in the top 50% of its subject field. In other words, these are journals that are most cited in their subject categories and can be considered a metric of impact of the research. 18 A review of traditional medicine research in Sri Lanka: 2015–2019 3.3 Results A total of 456 papers were identified for clinical research and case reports. The searching of grey literature provided the bulk of case reports. Fig. 3. PRISMA flow diagram for scoping review Records identified from databases (n = 226) Additional records identified through other sources (n = 230) Records screened (n = 456) Records excluded (n = 218) Records excluded (n = 38) Other countries, duplicates, not TM, not correct time period Systematic reviews (n = 3) RCTs & single-arm studies (n = 13) Case studies (n = 184) Id en tif ic at io n Sc re en in g In cl ud ed Records assessed for eligibility (n = 238) Identification of studies via databases and registers 3.3.1 Systematic reviews Three systematic reviews were identified, two of herbal interventions and one of yoga (37–39). Jayawardena et al. examined the effects of yoga compared with exercise in the management of type 2 diabetes. The review included eight RCTs and was published in a Q2 journal. None of the studies included were conducted in Sri Lanka. Both interventions were effective. Rajapakse et al. reviewed Carica papaya extract for dengue fever and it was published in a Q1 journal. Nine RCTs were included, none of which had been conducted in Sri Lanka. Study quality prevented a clear conclusion and the clinical value of Carica papaya extract improvement in platelet count or early discharge was unclear in the absence of more robust indicators of favourable clinical outcome. 19A review of traditional medicine research in Sri Lanka: 2015–2019 Ranasinghe et al. reviewed the medicinal benefits of Cinnamomum zeylanicum and included 70 studies. The review was published in a Q1 journal. None of the studies included had been conducted in Sri Lanka. 3.3.3 Randomized controlled trials and single-arm studies We included 13 randomized controlled trials, a single-arm safety study and a single-arm pre-test- post-test study. Interventions and conditions included four studies in metabolic conditions (diabetes), two studies in digestive disorders (gingivitis and peptic ulcers) and three studies in women’s health (dysfunctional uterine bleeding and polycystic ovarian syndrome). All of the published clinical trials had achieved ethics review approval prior to the commencement of the trials. We included any study that had preliminary results published and a single study protocol (40). Study interventions included complex, fixed Ayurvedic formulas, commercial products, pastes and single herbs. For the 13 RCTs, study controls were active interventions (n = 7), placebo (n = 2) or no interventions (n = 4). There were no individualized or semi-standardized studies. All of the clinical trials clearly mentioned the study setting and used inclusion and exclusion criteria. Some of the published trials mentioned the method used for sample size calculation. All of the trials included the baseline assessment. Primary outcomes and secondary outcomes were clearly mentioned in most of the trials. Few published trials included data handling and record- keeping methods in their protocols. Most of the trials were conducted by postgraduate researchers and trials were funded by government-based organizations. Funds were granted by the University Grants Commission (UGC), and NSF, Sri Lanka. Other trials were funded by private organizations or conducted in individual interests. Ten published clinical trials adhered to accepted methods in randomization in RCTs. Randomization methods included randomization sequence generated using an online randomization website (www.randomisation.com); block randomization method; and in two studies, individually sealed opaque envelopes were used (41,42). Five studies were published in peer-reviewed journals (Table 5). Four of these studies were in journals with a SCRImago Q ranking. Most studies were published in conference proceedings or journals with low impact. 20 A review of traditional medicine research in Sri Lanka: 2015–2019 Ta b le 4 . S tu dy c on di tio ns a nd in te rv en tio ns A u th o r C o n d it io n IC D -1 1 In te rv en ti o n # 1/ in te rv en ti o n # 2/ co n tr o l Pr im ar y o u tc o m e m ea su re s (A nu ru dd hi ka Su bh as hi ni e Se na dh ee ra , Ek an ay ak e, & W an ig at un ge , 2 01 5) D ia be te s M et ab ol ic 3. C om m er ci al ly p ro du ce d Sc op ar ia du lc is p or rid ge (S D C ) 3x /w ee ks 4. N on e FP G ; H bA 1c (D ah an ay ak e et a l., 20 20 a) * A lle rg ic r hi ni tis Re sp ira to ry 1. Ta m al ak ya di d ec oc tio n 12 0 m l 2 x/ da y 2. Fr ee ze d rie d Ta m al ak ya di d ec oc tio n, d is so lv ed in w at er 1 20 m l 2 x/ da y 3. Lo ra ta di ne 1 0 m g 1x /d ay To ta l N as al S ym pt om S co re ( TN SS ) (E di riw ee ra , P er er a, Pe re ra , P es ha la , & Ed iri si ng he , 2 01 5) A cn e Sk in 1. M an jis ta di ya p as te : ( Ru bi ac or di fo lia , C or ia nd ru m s at iv um , S an tu lu m a lb am , K ok oo na ze yl an ic a, C ur cu m a ar om at ic , C os ci ni um fe ne st ra tu m ) 2. Pl ac eb o pa st e Er up tio ns , p ai n, t en de rn es s (E ka na ya ka , Ru pa si nh a, So or iy ar ac hc hi , & G oo na ra tn a, 2 01 7) H yp er lip id em ia M et ab ol ic 1. Sw as th at hr ip ha la ( Te rm in al ia c he bu la 3 18 m g, Te rm in al ia b el le ric a 10 5 m g an d Ph yl la nt hu s em bl ic a 21 1 m g) p lu s at or va st at in 2. Pl ac eb o pl us a to rv as ta tin Se ru m li pi ds (H af ee l, M ob ee n, Ri zw an a, & Y as ir, 20 17 ) Pe pt ic u lc er D ig es tiv e Sy st em 1. Po w de r (A lo e ba rb ad en si s Li nn ., A st ra ga lu s sa rc ol la D ym oc k. , B os w el lia s er ra ta R ox b. , G ly cy rr hi za g la br a Li nn . a nd C om m ip ho ra m yr rh a En gl ), 4 g 3 x da ily N um be r an ds iz e of u lc er s in U G IT En do sc op y fin di ng s (H ow sh ig an , P er er a, Sa m ita , & R aj ap ak se , 20 16 ) G in gi vi tis D ig es tiv e Sy st em 1. Su da nt ha , A yu rv ed ic t oo th pa st e 2. Pl ac eb o to ot hp as te Q ui gl ey H ei n pl aq ue in de x (P S) , bl ee di ng o n pr ob in g (B O P) a nd pr ob in g po ck et d ep th ( PP D ) (K ar un an ay ak a, H et tih ew a, S ilv a, & K ar un an ay ak a, 2 01 8) H an d hy ge in e N /A 1. V ar io us a lc oh ol a nd n on -a lc oh ol h an d sc ru bs A nt im ic ro bi al e ff ic ac y m ea su re d by co un tin g th e nu m be r of m ic ro bi al co lo ni es u si ng a c ol on y co un te r (2 4 ho ur s af te r ap pl yi ng t he f or m ul a/ co nt ro l) 21A review of traditional medicine research in Sri Lanka: 2015–2019 A u th o r C o n d it io n IC D -1 1 In te rv en ti o n # 1/ in te rv en ti o n # 2/ co n tr o l Pr im ar y o u tc o m e m ea su re s (K um ar ap el i, K ar un ag od a, & Pe re ra , 2 01 8) Po ly cy st ic o va ria n sy nd ro m e En do cr in e 1. Sa ta pu sh pa -S ha ta va ri Po w de r (S SP ), 5 g o ra lly + 10 m l c ow g he e 2. Sa ta pu sh pa -S ha ta va ri G rit a (S SG ), 6 0 m l a s en em a 3. Bo th e ne m a an d po w de r Re du ct io n in u ltr as ou nd v ol um e, hi rs ut is m a nd m en st ru at io n im pr ov ed (P al lie , P er er a, G oo na se ka ra , K um ar as in gh e, & A ra w w aw al a, 2 02 0) D ia be te s En do cr in e 1. 12 0 m L of T ra gi ai nv ol uc ra ta L . d ec oc tio n 2x /d ay 2. 50 0 m g of m et fo rm in FP G , H bA 1c (H . P er er a, K ar un ag od a, P er er a, Sa m ar as in gh a, & A ra w w aw al a, 2 01 7) D ys fu nc tio na l ut er in e bl ee di ng G en ito ur in ar y 1. Bu m ya m al ak i ( Ph yl la nt hu s ni ru ri. ) 2. Pu sh ya nu ga C hu rn a H b% , B T, C T pl at el et , e nd om et ria l th ic kn es s (R aj av ar th an i S e t al , 20 18 ) Rh eu m at oi d ar th rit is M us cu lo sk el et al sy st em 1. Ra sn as ap th ak ay a de co ct io n pl us d rie d gi ng er po w de r (d is so lv ed ), 1 20 m l 2 x/ da ily 2. Ru m al ay a ta bl et 5 00 m g 2x /d ai ly PR IM A RY : F ul l b lo od c ou nt , E SR , rh eu m at oi d fa ct or ( RF ) (V PS S en ev ira tn e, H ap ua ra ch ch i, Pe re ra , & d e Zo ys a, 20 17 ) Se le ct ed co gn iti ve fu nc tio ns N er vo us s ys te m 1. C en te lla as ia tic a ca pl et s (5 00 m g) 1 x/ da y 2. G ot uk ol a ca pl et s sa m e do se w ith c ow ’s m ilk C ha ng e in M M SE a nd M on tr ea l– C og ni tiv e A ss es sm en t (M oC A ) sc or es V ar na ku le nd re n N (2 01 8) A na em ia Bl oo d 1. A ya bi ru ng ar aj ak ar pa m ( A BK ) ca ps ul e 50 0 m g w ith li m e ju ic e tw ic e pe r da y fo r 48 d ay s (W ee ra ko on , P er er a, G un as ek er a, & Su re sh , 2 01 6) fe ve r Sa fe ty 2. Su da rs ha na ( Ph as e I s tu dy ) H ea lth y vo lu nt ee rs d id n ot r ep or t an y ad ve rs e ef fe ct s or a ny o th er co m pl ic at io ns d ur in g tr ea tm en t an d fo llo w -u p W ee ra ko on W A SS , D ul an i G un as ek ar a fe ve r In fe ct io us o r pa ra si tic 1. Su da sh an a su sp en si on 3 12 .5 m g/ kg /2 4 hr s 2. Su da rs ha na p ow de r (P ha se II s tu dy ) N ot es : * pr ot oc ol o nl y 22 A review of traditional medicine research in Sri Lanka: 2015–2019 Ta b le 5 . S tu dy c ha ra ct er is tic s A u th o r Jo u rn al /C o n fe re n ce Jo u rn al Sa m p le St u d y d es ig n B lin d in g Le n g th o f st u d y (A nu ru dd hi ka S ub ha sh in ie Se na dh ee ra e t al ., 20 15 ) BM C C A M Q 1 (C A M ) 35 RC T cr os so ve r N on e 3 m on th s (D ah an ay ak e et a l., 2 02 0b ) Pr ot oc ol p ub lis he d/ co nf er en ce p ro ce ed in gs * Q 1 70 /7 0/ 70 RC T op en la be l N on e 14 d (E di riw ee ra e t al ., 20 15 ) Jo ur na l o f A yu rv ed a H ol is tic M ed ic in e N ot li st ed 60 RC T N on e 30 d (E ka na ya ka e t al ., 20 17 ) C ey lo n M ed J Q 3 (M ed ic in e, m is c. ) 19 8 RC T D ou bl e 3 m th s (H af ee l e t al ., 20 17 ) In te rn at io na l J ou rn al o f C ur re nt A dv an ce d Re se ar ch N ot li st ed 22 Pr e- te st -p os t-t es t N on e 30 d (H ow sh ig an e t al ., 20 16 ) C ey lo n M ed J Q 3 (M ed ic in e, m is c. ) 66 RC T Si ng le 6 m th s (K ar un an ay ak a et a l., 20 18 ) In te rn at io na l S ym po si um o n A yu rv ed a an d in di ge no us m ed ic in e (I SA IM 2 01 8) C on f. 33 0 RC T Si ng le 1 d (K um ar ap el i e t al ., 20 18 ) In te rn at io na l J ou rn al o f Ph ar m ac eu tic al Sc ie nc es a nd R es ea rc h N ot li st ed 60 O pe n la be l R C T Si ng le (P al lie e t al ., 20 20 ) C lin ic al T ria ls in D eg en er at iv e D is ea se s N ot li st ed 36 /3 6 RC T co m pa ra tiv e ef fe ct iv en es s N on e 14 d (H . P er er a et a l., 2 01 7) Th e Se cr et ar ia t of IC A U ST –2 01 5 an d A Y U EX PO C on f. 60 RC T Si ng le 16 w ks (R aj av ar th an i S e t al , 2 01 8) C on fe re nc e pr oc ee di ng s C on f. 30 RC T N on e 14 d (V PS S en ev ira tn e et a l., 20 17 ) Pr oc ee di ng s of t he T ra dm ed In te rn at io na l Sy m po si um C on f. 30 /3 0 O pe n la be l, RC T N on e 12 w ks V ar na ku le nd re n N ( 20 18 ) Th es is o nl y N /A 11 6 Pr e- te st -p os t-t es t N on e 90 d (W ee ra ko on e t al ., 20 16 ) Pr oc ee di ng s of t he S ec on d In te rn at io na l C on fe re nc e on N at ur al P ro du ct s G en om ic s C on f. 35 sa fe ty N on e W ee ra ko on W A SS , D ul an i G un as ek ar a Th es is o nl y N ot li st ed 42 RC T N on e 3 d N ot e: * Th is s tu dy w as lo ca te d as a n ab st ra ct f ro m c on fe re nc e pr oc ee di ng s in 2 01 9. H ow ev er , t he c om pl et e st ud y pr ot oc ol w as p ub lis he d in 2 02 0 an d ha s be en in cl ud ed a s a m or e co m pl et e re fe re nc e he re . 23A review of traditional medicine research in Sri Lanka: 2015–2019 3.3.4 Studies listed on WHO registries and ERC There were 19 trials listed on the Sri Lankan Clinical Trials Register (SLCTR) and/or the ISRCTN between January 2015 and November 2019, regardless of status, related to herbal medicines. ISRCTN is a clinical trial registry recognized by WHO and International Committee of Medical Journal Editors (ICMJE) that accepts planned, ongoing or completed studies of any design. All SLCTR studies are automatically registered on ISRCTN. Progress reports were inconsistently available on the database to provide clarity on which studies may have been abandoned. Of those studies that were located on the clinical trial registries, seven RCTs have not clearly mentioned masking in their protocols. Six trials described using single blinding, six double blinding methods and some were open label trials (Table 7). Most (73%) of the research studies registered on WHO-accepted trial registries used a randomization design and appeared to meet accepted trial standards (Tables 6 and 7). Among these, three trial protocols were published in accepted peer review journals before starting the trial. One published trial protocol used a “double classification” method where subjects primarily met Western diagnostic criteria and then were further classified according to the Ayurveda system. Two protocols were published in a journal and followed the requirements of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (42). Within those studies on the clinical trial registries, clear efforts were evidently made to follow the CONSORT (Consolidated Standards of Reporting Trials) guidelines (http://www.consort-statement.org/). Table 6. Sri Lankan herbal drug trials registered on WHO-accepted trial registries Ethics committee Research title Condition Registration Status University of Jayewardenepura A phase I study of the safety, possible toxicity of a novel Ayurvedic preparation, Sudarshana suspension Safety SLCTR/2015/005 Complete University of Jayewardenepura A phase I study of the possible toxicity of the Ayurvedic preparation, Rasnasapthakaya Safety SLCTR/2015/006 Complete University of Jaffna Hypoglycaemic and antioxidant activity of the Siddha medical preparation, Mathumehachooranam, in patients with diabetes mellitus Diabetes SLCTR/2015/008 Recruiting University of Ruhuna The efficacy of Costusspeciosus leaves on the postprandial glucose surge in healthy subjects; a clinical trial Diabetes SLCTR/2015/011 Withdrawn University of Kelaniya A randomized control trial of virgin coconut oil in the treatment of Alzheimer’s dementia (VCO–AD study) Dementia SLCTR/2015/018 Partially complete (F/Up) 24 A review of traditional medicine research in Sri Lanka: 2015–2019 Ethics committee Research title Condition Registration Status University of Ruhuna Phase II clinical trial – the effects of extract of Costusspeciosus (thebu) on hepatic insulin resistance and biochemical profile of patients with non-alcoholic fatty liver disease NAFL SLCTR/2015/019 Recruiting University of Jayewardenepura Therapeutic evaluation of the antipyretic activity of the Ayurvedic preparation, Sudarshana suspension, in febrile children Fever SLCTR/2015/026 Complete University of Jayewardenepura A phase II/III study of the anti-inflammatory activity of Rasnasapthakaya decoction in patients with rheumatoid arthritis Rheumatoid arthritis SLCTR/2015/028 Complete University of Jaffna Supplement effect of Cherukurinja (Gymnemalactiferum) on glycemic control and on selected biochemical and physiological parameters among patients with type 2 diabetes mellitus Diabetes SLCTR/2016/007 Recruiting University of Colombo Effectiveness of Cinnamomum zeylanicum (Ceylon cinnamon) in lowering blood glucose in type 2 diabetes mellitus: arandomized double-blind placebo controlled clinical trial Diabetes SLCTR/2017/010 Recruiting (protocol) University of Jaffna Efficacy of Silymarin (milk thistle fruit extract) compared to a placebo in improving liver fibrosis in patients with non- alcoholic fatty liver disease, a pilot study NAFL SLCTR/2017/016 Recruiting Rajarata University of Sri Lanka Effect of papaya (Carica papaya) leaf extract on plasma leakage and platelet count in dengue fever: a randomized controlled trial Dengue SLCTR/2017/034 Recruiting University of Colombo A randomized controlled trial to compare the efficacy of topical Ayurvedic oil preparation against placebo in symptomatic knee osteoarthritis Knee osteoarthritis SLCTR/2017/039 Recruiting 25A review of traditional medicine research in Sri Lanka: 2015–2019 Ethics committee Research title Condition Registration Status University of Ruhuna Effect of a standardized herbal capsule of Cocciniagrandis (L.) Voigt on selected metabolic parameters in patients with type 2 diabetes mellitus: a randomized controlled trial Diabetes SLCTR/2018/012 Complete IIM, University of Colombo Compare the effects of two Ayurveda drug regimens on the treatment of uterine fibroids Obstetrics and gynaecology ISRCTN16108738 Complete (protocol) IIM, University of Colombo Comparing the effects of two Ayurveda drugs on the treatment of allergic rhinitis Allergic rhinitis ISRCTN18149439 Recruiting (protocol) Rajarata University of Sri Lanka Pharmacotherapeutic and physicochemical evaluation of Ayabirungarajakarpam – a poly herbometallic drug for Paandu –anaemia Anaemia SLCTR/2018/035 Complete Ethics Review Committee, Medical Research Institute, Ministry of Health Formulation and evaluation of the antimicrobial efficacy of novel alcohol-based and non- alcohol-based natural hand scrubs with medicinal plant extracts Antimicrobial SLCTR/2019/016 Complete University of Ruhuna Dietary behaviour of patients with urolithiasis and anti- urolithic effects of selected local fruits Kidney SLCTR/2019/031 Recruiting 26 A review of traditional medicine research in Sri Lanka: 2015–2019 Table 7. Study design methods used in trials registered on WHO-accepted trial registries Method used No. of trials (%) The Sri Lanka Clinical Trials Registry (SLCTR) – Reference Study type Interventional (19) 100 SLCTR/2015/005 SLCTR/2015/006; SLCTR/2015/008 SLCTR/2015/011; SLCTR/2015/018; SLCTR/2015/019; SLCTR/2015/026; SLCTR/2015/028; SLCTR/2016/007 SLCTR/2017/010; SLCTR/2017/016; SLCTR/2017/034 SLCTR/2017/039; SLCTR/2018/012; ISRCTN16108738; ISRCTN18149439; SLCTR/2018/035; SLCTR/2019/016; SLCTR/2019/031 Study design allocation RCT (14) 73.7 SLCTR/2015/011 SLCTR/2015/018 SLCTR/2015/019 SLCTR/2015/028 SLCTR/2016/007 SLCTR/2017/010 SLCTR/2017/016 SLCTR/2017/034 SLCTR/2017/039 SLCTR/2018/012 ISRCTN16108738 ISRCTN18149439 SLCTR/2019/016 SLCTR/2019/031 Non-RCT (5) 26.3 SLCTR/2015/026; SLCTR/2015/005; SLCTR/2015/006 SLCTR/2015/008; SLCTR/2018/035 Masking Double blinded (6) 31.6 SLCTR/2015/018 SLCTR/2015/019 SLCTR/2016/007 SLCTR/2017/010 SLCTR/2017/039 SLCTR/2018/012 Single blind (6) 31.6 SLCTR/2015/008 SLCTR/2015/011 SLCTR/2015/026 ISRCTN16108738 ISRCTN18149439 SLCTR/2019/016 None (7) 36.8 SLCTR/2015/005 SLCTR/2015/006 SLCTR/2015/028 SLCTR/2017/016 SLCTR/2017/034 SLCTR/2018/035 SLCTR/2019/031 Control Placebo (8) 42.1 SLCTR/2015/018 SLCTR/2015/019 SLCTR/2017/010 SLCTR/2017/016 SLCTR/2017/039 SLCTR/2018/012 No control (3) 15.8 SLCTR/2015/005 SLCTR/2015/006 SLCTR/2018/035 Standard therapy (6) 31.6 SLCTR/2015/008 SLCTR/2015/028 SLCTR/2017/034 ISRCTN16108738 ISRCTN18149439 SLCTR/2019/031 Active (2) 10.5 SLCTR/2019/016 SLCTR/2016/007 Assignment Single (3) 15.8 SLCTR/2015/006 SLCTR/2015/008 SLCTR/2018/035 Parallel (11) 57.9 SLCTR/2015/011 SLCTR/2015/018 SLCTR/2015/026 SLCTR/2015/028 SLCTR/2015/028 SLCTR/2016/007 SLCTR/2017/034 SLCTR/2018/012 ISRCTN16108738 ISRCTN18149439 SLCTR/2019/031 27A review of traditional medicine research in Sri Lanka: 2015–2019 Method used No. of trials (%) The Sri Lanka Clinical Trials Registry (SLCTR) – Reference Purpose Treatment (13) 68.4 SLCTR/2015/008 SLCTR/2015/018 SLCTR/2015/019 SLCTR/2015/026 SLCTR/2015/028 SLCTR/2017/010 SLCTR/2017/016 SLCTR/2017/034 SLCTR/2017/039 SLCTR/2018/012 ISRCTN16108738 ISRCTN18149439 SLCTR/2018/035 Other (2) 10.5 SLCTR/2015/005 SLCTR/2019/016 Basic science (2) 10.5 SLCTR/2015/011 SLCTR/2016/007 Health services (1) 5.3 SLCTR/2019/016 Prevention (1) 5.3 SLCTR/2019/031 During the five-year period of this review, 157 (90%) clinical trials on the Sri Lanka Clinical Trials Registry were for Western medicine (Fig. 4). Research relating to indigenous medicine/Ayurveda comprised the remaining 10%. Fig. 4. Overview of clinical trials registered on the Sri Lankan Clinical Trial Registry in each sector (20 January 2015 to 10 November 2019) 0 10 20 30 40 50 2015 2016 2017 2018 2019 Ayurveda/Traditional medicine Western medicine 28 A review of traditional medicine research in Sri Lanka: 2015–2019 3.3.5 Case reports: Case series and case studies There were 184 case control, case studies and case series undertaken to examine the use of TM in a wide variety of diseases and conditions during 2015–2019 (Table 8). The bulk of these were published as posters or conference proceedings and few in peer-reviewed, indexed journals. Of the 186 studies, few articles were published in international peer-reviewed journals. Nearly 88.7% case studies and case series (Fig. 5) were conducted on Ayurvedic medicine with only 8.6% on Unani and 2.7% on Siddha medicine. Fig. 5. Comparison of case studies/case series by different TM systems in Sri Lanka during 2015–2019 0 50 100 150 200 Ayurveda/ Indigenous medicine Unani Siddha The majority of case reports included traditional panchkarma therapies such as the use of herbal oils, body treatments (including oil massage), steam therapy, herbal paste therapy, nasal therapy, vomiting therapies, enema therapy and purgation therapies. For example, case reports included: Kshara is an Ayurvedic procedure, derived from a combination of various herbs, that is applied to the pile mass with the help of a special slit proctoscope. Parisheka Sveda is where a medicated liquid is to be poured over the desired part or the whole body. Janu Vasti is where the janu (knee) is subjected to a therapy called vasti (warm, medicated oil placed over the knee joint). Vasti denotes “a compartment that holds” (in this case, a pool of medicated oil). The main conditions or diseases investigated in the case reports included skin, fractures and diabetes. Obesity and cardiovascular risk factors have also been the subject of a growing number of case studies (Fig. 6). 29A review of traditional medicine research in Sri Lanka: 2015–2019 Ta b le 8 . C ha ra ct er is tic s of c as e st ud ie s an d ca se s er ie s in S ri La nk a (2 01 5– 20 19 ) St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e A n A yu rv ed ic a pp ro ac h in t he m an ag em en t of M en ie re ’s d is ea se – A c as e st ud y (A be gu na se ka ra , 2 01 6) H er b M en ie re ’s C ar di ov as cu la r A yu rv ed a A c lin ic al e va lu at io n of t he e ff ic ac y of “s ha db in du ta ila ” na sy a in t he m an ag em en t of “g riv as an di ga ta va ta ” (c er vi ca l s po nd yl os is ) (A lw is & S ilv a, 2 01 7) N as ya C er vi ca l sp on dy lo si s M us cu lo sk el et al A yu rv ed a U se o f A yu rv ed a an d Sr i L an ka n tr ad iti on al m ed ic in e fo r he al in g sh af t of h um er us f ra ct ur e fo llo w in g no nu ni on (A . A tt an ay ak e, D e Si lv a, J ay aw ee ra , & Pe re ra , 2 01 8) To pi ca l ap pl ic at io n Fr ac tu re M us cu lo sk el et al A yu rv ed a/ In di ge no us m ed ic in e Ev al ua tio n of t he t he ra pe ut ic e ff ec t of tr ip ha la ka ta ka np at a de co ct io n an d as se ss in g th e qu al ity o f lif e am on g di ab et es m el lit us pa tie nt s (A . P . A tt an ay ak e, 20 15 ) D ec oc tio n D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a A ss es sm en t of f ra ct ur e he al in g fo llo w in g A yu rv ed a tr ea tm en t in m al un io n di st al ra di us c om m in ut ed f ra ct ur e of w ris t w ith ou t re m ov in g th e in te rn al f ix at or : A c as e st ud y (A . P . A tt an ay ak e, 20 16 ) To pi ca l ap pl ic at io n Fr ac tu re M us cu lo sk el et al A yu rv ed a H ea lin g ef fe ct o f Sr i L an ka n tr ad iti on al a nd A yu rv ed a m ed ic in e in c om m in ut ed f ra ct ur e ov er s ha ft o f tib ia f ol lo w in g no nu ni on : A c as e re po rt (A . P . A tt an ay ak e, Si lv er , & J ay aw ee ra , 20 17 ) To pi ca l ap pl ic at io n Fr ac tu re M us cu lo sk el et al A yu rv ed a Ev al ua tio n of t he c lin ic al e ff ic ac y of H ee n Bo w iti ya le av es [ O sb ec ki ao ct an dr a] p ha nt a in th e m an ag em en t of d ia be te s m el lit us (B al as oo riy a, 2 01 6) H er b D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a A c as e st ud y on t he m an ag em en t of ha em or rh oi da l p ro la ps e (B at vi th a, 2 01 8) H er b H ae m or rh oi ds C ar di ov as cu la r A yu rv ed a A pp lic at io n of K sh ar a in t he m an ag em en t of fis tu la in a no : A c as e st ud y (B av ith a, 2 01 8) K sh ar a ap pl ic at io n Fi st ul a Sk in A yu rv ed a 30 A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e A c as e st ud y on a ss es sm en t of A yu rv ed a tr ea tm en t m od al ity in a de no ca rc in om a in co lo n (B M A RI , 2 01 7) H er b C an ce r D ig es tiv e A yu rv ed a A n as se ss m en t of e ff ec tiv en es s of t ra di tio na l an d pr oc ed ur es f or C K D b y tr ad iti on al pr ac tit io ne r of S uw a U da na W ed a Pi ya sa (B M A RI , 2 01 7) H er b C hr on ic k id ne y di se as e A yu rv ed a/ In di ge no us m ed ic in e A s tu dy o n ef fe ct iv en es s of t ra di tio na l pr ac tic es f or C K D b y tr ad iti on al p ra ct iti on er o f M ah av ila ch ch iy a cl in ic (B M A RI , 2 01 7) H er b C hr on ic k id ne y di se as e U ro lo gi ca l In di ge no us m ed ic in e A c as e st ud y on t he e ff ic ac y of a n A yu rv ed a dr ug r eg im en o n cl in ic al s ym pt om s an d se le ct ed b io ch em ic al p ar am et er s on c hr on ic ki dn ey d is ea se p at ie nt s (B M A RI , 2 01 7) H er b C hr on ic k id ne y di se as e U ro lo gi ca l A yu rv ed a C lin ic al a ss es sm en t of p os t de ng ue co m pl ic at io ns b ef or e an d af te r A yu rv ed a tr ea tm en ts – c as e se rie s (B M A RI , 2 01 7) H er b D en gu e fe ve r G en er al un sp ec ifi ed A yu rv ed a Ev al ua tio n of t he ra pe ut ic e ff ec t of th rip ha la ka ta ka na p at a de co ct io n on d ia be te s m el itu s (B M A RI , 2 01 7) D ec oc tio n D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a A c as e re po rt o n as se ss m en t of t he f ra ct ur e he al in g ef fe ct f or g re en s tic k fr ac tu re w ith ou t la te ra l a ng ul at io n (B M A RI , 2 01 7) To pi ca l ap pl ic at io n Fr ac tu re M us cu lo sk el et al A yu rv ed a Ev al ua te t he e ff ic ac y of a n A yu rv ed a tr ea tm en t re gi m en o n ut ta na va ta ra kt a – ca se s tu dy (B M A RI , 2 01 7) H er b G ou t En do cr in e/ M et ab ol ic a nd nu tr iti on al A yu rv ed a Ev al ua tio n of t he ra pe ut ic e ff ec t of a tr ad iti on al h er ba l f or m ul a (D T6 p ow de r) o n hy pe rg ly ce m ia (B M A RI , 2 01 7) H er ba l p ow de r H yp er gl yc em ia En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a 31A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e C as e se rie s on m an ag em en t of h yp er lip id em ia w ith p ol yh er ba l f or m ul at io ns (B M A RI , 2 01 7) H er b H yp er lip id em ia En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a C lin ic al s tu dy o f “m ed a D hu sh ta L ak sh an a” be fo re a nd a ft er v am an a ka rm a (B M A RI , 2 01 7) Em et ic Li pi d di so rd er En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a Ef fe ct o f El -V ire ka , M ud ga di K as ha ya a nd Tr ip ha la U dv ar ta na in a th is th au ly a (o be si ty ) – A c as e st ud y (C ha nd ra si ri & Ed iri w ee ra , 2 01 9) D ec oc tio n O be si ty En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a Ev al ua tio n of e ff ic ac y of S ih in M id i (P re m na in te gr ifo lia L .) d ec oc tio n in a th is ta ul ya (o be si ty ) pa tie nt s (D e Si lv a, H ap ua ra ch ch i, H ar ap at hd en iy a, & Pe re ra , 2 01 7) D ec oc tio n O be si ty En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a Th er ap eu tic e ff ic ac y of t he d ec oc tio n of Pr em na in te gr ifo lia L in n in t he m an ag em en t of ob es ity ( at hi st ha ul ya ): A c as e st ud y (D e Si lv a, 2 01 8) D ec oc tio n O be si ty En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a A c lin ic al s tu dy c om pa rin g th e ef fic ac y of t he d ec oc tio ns o f G as ka ra lh eb a (A ch yr an th es as pe ra ) an d H at ha va riy a (A sp ar ag us r ac em os us ) in t he t re at m en t of sr av ia rs ha s (b le ed in g pi le s) (D is sa na ya ka , 2 01 7) D ec oc tio n H ae m or rh oi ds C ar di ov as cu la r A yu rv ed a C om pa ra tiv e cl in ic al s tu dy o n th e ef fic ac y of t re at m en t fo r sr av ia rs ha s (b le ed in g pi le s) us in g th e de co ct io ns o f Ra th ka ra lh eb a (C ya th ul la pr os tr at a) a nd G as ka ra lh eb a (A cy ra nt he sa sp er a) (D is sa na ya ke , 2 01 5) D ec oc tio n H ae m or rh oi ds C ar di ov as cu la r A yu rv ed a Ef fe ct o f Po st e A na r an d Sa fo of e Z aj in H ik ka th ul F ar zj : A p re lim in ar y st ud y (F ar za na & S ul ta na , 20 16 ) 1. P ow de r an d po m eg ra na te (P un ic ag ra na tu m L. ) de co ct io n H ik ka th uF ar zj (P ru rit is v ul va e) Fe m al e ge ni ta l U na ni 32 A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e A c as e st ud y on V ar m gh ud ad ad ar qi yy ah (t hy ro id s w el lin g) (F az ee na h, 2 01 8) H er b G oi tr e En do cr in e/ m et ab ol ic a nd nu tr iti on al U na ni Ev al ua tio n of U na ni t re at m en t m od al ity in m yo ca rd ia l i nf ar ct io n – ca se s tu dy (F az m iy a & S ew w an di , 20 17 ) H er b M yo ca rd ia l in fa rc tio n C ar di ov as cu la r A yu rv ed a A p ro sp ec tiv e of m od ifi ed U na ni t he ra pe ut ic s fo r ga lls to ne ( H as at -e -M ira ra h) – c as e se rie s (F az m iy a, 2 01 5) H er b C ho le lit hi as is D ig es tiv e U na ni A c lin ic al s tu dy o n th e ef fic ac y of S ap ta W in sa ti G ug gu lu in t he m an ag em en t of su sh ka ar sa (F er na nd o, 2 01 6) H er ba l p ill s H ae m or rh oi ds D ig es tiv e A yu rv ed a M an ag em en t of h yp er lip id em ia (m ed ho vr ud dh i) w ith t he u se o f A yu rv ed ic a nd tr ad iti on al m ed ic in e: A c as e st ud y (G am ag e, W el iv iti go da , & K is ho lo rja n, 2 01 7) H er b Li pi d di so rd er En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a M an ag em en t of A va bh ah uk a (f ro ze n sh ou ld er ) th ro ug h Sr i L an ka n A yu rv ed a tr ea tm en t pr ot oc ol : A c as e st ud y (G un ar at hn a & K ul at hu ng a, 2 01 9) H er b Fr oz en s ho ul de r M us cu lo sk el et al A yu rv ed a/ In di ge no us m ed ic in e Le ec h ap pl ic at io n fo r m an ag em en t of in fla m ed ha em or rh oi ds : A c as e st ud y (G un ar at hn a, 2 01 8) Le ec h th er ap y H ae m or rh oi ds C ar di ov as cu la r A yu rv ed a C lin ic al e va lu at io n of S he et a K as ha ya o f H ib is cu s fu rc at us w ith a nd w ith ou t va m an a ka rm a w ith L in de rn ia pu si lla in t he c as es of p ra m eh a- m ad hu m eh a (t yp e 2 di ab et es m el lit us ) (G un at ila ka , E di riw ee ra , W ee ra si ng he , & K ar un ar at hn e, 2 01 5) H im ak as ay a (c ol d he rb al d ec oc tio n) + em et ic s D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a Ef fe ct iv en es s of S yz yg iu m cu m in i ( na va l) ro ot d ec oc tio n of o n di ab et ie s m el lit us (m at hu m ea ha m ) (H as an a, 2 01 6) D ec oc tio n D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a U na ni a pp ro ac h to p ar al ys is ( fa lij ) – A c lin ic al co nt riv e (J ab ee n, 2 01 7) H er b H em ip le gi a N eu ro lo gi ca l U na ni 33A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e A c as e st ud y on e ff ec tiv en es s of d ry c up pi ng in fr oz en s ho ul de r (J am al de en & R is m iy a, 20 17 ) C up pi ng Fr oz en s ho ul de r M us cu lo sk el et al U na ni /C up pi ng C lin ic al e ff ic ac y an d an tib ac te ria l a ct iv ity o f Pa nc ha w al ka la A va ga ha in t he m an ag em en t of h ae m or rh oi ds (J ay ak od y an d Pu sh pa ku m ar a, 2 01 7) Si tz ba th H ae m or rh oi ds C ar di ov as cu la r A yu rv ed a A c om pa ra tiv e st ud y on t he e ff ec t of B ha dr ad i N iru ha V as ti an d Le kh an ad i C hu rn a or al ly in t he m an ag em en t of a tis th au ly a W .S .R .t o ob es ity (J ay al at h, 2 01 6) En em a + or al he rb al p ow de r O be si ty En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a Ef fe ct iv en es s of D as an ga G ug gu lu in o be si ty (J ay as in gh e, 2 01 6) H er ba l p ill s O be si ty En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a C lin ic al a ss es sm en t of e ff ic ac y an d sa fe ty pr of ile o f D as an ga G ug gu lu c om pa re d w ith tr ip al ac hu rn a in m an ag em en t of o be si ty (J ay as in gh e, K ul at un ga an d Ra tn ap al a, 2 01 7) H er ba l p ill s O be si ty En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a In te gr at ed a pp ro ac h fo r m an ag in g ad en oc ar ci no m a of c om m on b ile d uc t – a ca se re po rt (J ay as un da ra , K al ut ho ta ge e t al . 20 16 ) H er ba l de co ct io n + he rb al m in er al dr ug s Bi le d uc t ca nc er D ig es tiv e A yu rv ed a/ In di ge no us m ed ic in e A n ex pe rim en ta l s tu dy o n th e ef fe ct iv en es s of t ra di tio na l l oc al a pp lic at io n fo r kn ee jo in t co nt us io n (J ay aw ar dh an e, 2 01 5) H er b C on tu si on M us cu lo sk el et al A yu rv ed a A ss es sm en t of t he o ut co m e of A yu rv ed ic tr ea tm en ts f or v er te br al f ra ct ur e w ith m ot or dy sf un ct io n (J ay aw ee ra e t al ., 20 18 ) H er b Fr ac tu re M us cu lo sk el et al A yu rv ed a Th er ap eu tic e ff ec ts o f in di ge no us h er bs a nd it s im pa ct o n H IV /A ID S su bj ec ts (K am as hi a nd S ug um a, 20 17 ) H er b H IV /A ID S Bl oo d, b lo od - fo rm in g or ga ns an d im m un e m ec ha ni sm A yu rv ed a/ In di ge no us m ed ic in e 34 A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e C lin ic al s tu dy o n th e ef fic ac y of t he N ik ãd i T ai la in t he m an ag em en t of S ñr yã va rt a (K ar un ar at hn a, 2 01 5) To pi ca l ap pl ic at io n M ig ra in e N eu ro lo gi ca l A yu rv ed a St ud y on e ff ec t an d ef fic ac y of le ec h th er ap y an d V el la ng iri ya d ec oc tio n in t he m an ag em en t of m ig ra in e (s hi ro bh ita pa ) (K ee rt hi ra th ne , 2 01 6) Le ec h th er ap y + de co ct io n M ig ra in e N eu ro lo gi ca l A yu rv ed a A c as e st ud y on e ff ec t of A yu rv ed ic t re at m en t in t he m an ag em en t of g al lb ad de r ca lc ul i (K ee rt hi ra th ne , 2 01 8) H er b G al ls to ne s D ig es tiv e A yu rv ed a C lin ic al s tu dy o n th e ef fic ac y of t he s pe ci al ly pr ep ar ed B rih at i s yr up in t he m an ag em en t of dr y co ug h (v ãt a- pi tt aj ak ãs a) (K um ar a, 2 01 5) H er ba l s yr up C ou gh Re sp ira to ry A yu rv ed a A c lin ic al c as e st ud y to e va lu at e th e ef fic ac y of N ee ly ad i o il lo ca l a pp lic at io n fo r pa rt ia l fis tu lo to m y fo llo w ed b y K sh ar as ut hr a th er ap y in t he m an ag em en t of B ag an da ra w ith s pe ci al re fe re nc e to f is tu la in a no (K um ar a, 2 01 5) To pi ca l ap pl ic at io n Fi st ul a Sk in A yu rv ed a In tr od uc tio n of n ew li ne o f tr ea tm en t re gi m e on n on -a lc oh ol ic f at ty li ve r di se as e (N A FL D ) (y ak ru th da ly au da ra ) – A c as e st ud y (K um ar a, d e Si lv a an d Sa ku nt ha la , 2 01 7) H er b Fa tt y liv er D ig es tiv e A yu rv ed a Th e as se ss m en t of t he c ur in g ef fe ct o f Th al ai pe an ko lli th ai la m ( he rb al o il) o n th os e af fe ct ed b y th al ai pe an ( he ad lo us e) (K um ut ha ra nj an , 2 01 8) To pi ca l ap pl ic at io n H ea d lic e Sk in Si dd ha Ef fe ct iv en es s of m ah av ar th ik av a pi ll on es ch er ic hi a co li (L iy an ag e, 2 01 5) H er ba l p ill s E. c ol i D ig es tiv e A yu rv ed a Pa da ns hi ka k ar m a in t he m an ag em en t of su dd en w ith dr aw al o f ok as at hm ya ah ip he na ad di ct io n: A c as e st ud y (L iy an ag e, 2 01 8a ) H er b D ru g ab us e Ps yc ho lo gi ca l A yu rv ed ic m an ag em en t of b ip ol ar a ff ec tiv e di so rd er : A c as e re po rt (L iy an ag e, H et tig e et a l. 20 17 ) H er b Bi po la r Ps yc ho lo gi ca l A yu rv ed a 35A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e St ud y th e qu al ity o f lif e fo llo w in g K sh ar a su tr a tr ea tm en t fo r fis tu la in a no (M ad us ha ni , 2 01 6) K sh ar a ap pl ic at io n Fi st ul a Sk in A yu rv ed a In te rv en tio n of w ei gh t re du ct io n de si gn ed fo r ob es ity r em ed ie d on c hr on ic a nd s ev er e ar th rit is o n bo th k ne es : c as e st ud y (M an uh a, 2 01 5) W ei gh t co nt ro l O be si ty En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a Ev al ua tio n of t he ra pe ut ic e ff ec t of M ad hu m eh ar iv at i o n hy pe rg ly ca em ia (M en di s, 2 01 6) H er ba l p ill s D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a H yp og ly ca em ic e ff ec t of T he bu a m on g hy pe rg ly ca em ic p at ie nt s (M ut ha lib , 2 01 6) H er b D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a/ In di ge no us m ed ic in e M an ag em en t of V ic ha rc hi ka t hr ou gh A yu rv ed a: A c as e st ud y (N ila ni , 2 01 8) H er b Ec ze m a Ec ze m a A yu rv ed a Pi lo t st ud y of e ff ic ac y of s in gl e Se va ra th ai le av es f or V el la in oi –L eu co rr ho ea (N iru ba , 2 01 6) H er b Le uc or rh oe a Fe m al e ge ni ta l A yu rv ed a Ef fe ct o f Eu ph or bi a hi rt a on t he m an ag em en t of c on st ip at io n (m al ak ka dd u) (P ah ee ra th an , 2 01 5) H er b C on st ip at io n D ig es tiv e A yu rv ed a A yu rv ed ic m an ag em en t of m yo si tis o ss ifi ca ns of v as tu s la te ra lis m us cl e (u ru st ha m ba ): A c as e st ud y (P au de l, K um ar a nd G op ik ris hn a, 2 01 7) H er b M yo si tis M us cu lo sk el et al A yu rv ed a Ev al ua te t he e ff ic ac y of a d ru g fo rm ul a (K L C ho or na ) on p ro te in ur ia in c hr on ic k id ne y di se as e (C K D ) pa tie nt s (P er ar a, 2 01 7) H er ba l p ow de r K id ne y di se as e U ro lo gi ca l A yu rv ed a C lin ic al s tu dy o f su cc es sf ul d ev el op m en t in he al th t ou ris m v ia S hi ro dh ar a tr ea tm en t fo r an xi et y, d ep re ss io n an d in so m ni a (P er er a, 2 01 6) Sh iro dh ar a D ep re ss io n Ps yc ho lo gi ca l A yu rv ed a In di ge no us a pp ro ac h in t he m an ag em en t of re na l c al cu li (m ut hr as hm ar i): A c as e re po rt (P er er a, 2 01 8) H er b ne ph ro lit hi as is U ro lo gi ca l In di ge no us m ed ic in e 36 A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e C lin ic al s tu dy o f th e ef fe ct iv en es s of p re pa re d fo rm ul a fo r th e ac ne v ul ga ris (P iy at hi la ka , K um ar a et al . 2 01 6) Pa st e (C or ia nd ru m sa tiv um , A co ru sc al am us , Sy m pl oc us . C oc hi nc hi ne ns is , Sa us su re al ap pa ) A cn e Sk in A yu rv ed a Ev al ua tio n of t he e ff ec t of H in gu ad ile pa in t he m an ag em en t of K ha da ra ( co rn s) (P ra m od an i, 20 15 ) To pi ca l ap pl ic at io n C or n Sk in A yu rv ed a C lin ic al e va lu at io n of T rip al ad i U dv ar ta na fo llo w ed b y sa rv an ga sw ed a in t he m an ag em en t of o be si ty ( st ha ul ya ) (P ra m od an i, 20 16 ) U dv ar th an a O be si ty En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a A s tu dy o n ef fe ct o f N as ya K ar m a an d Th ila di le pa in t re at m en t of Y uv an aP id ak a (a cn e vu lg ar is ) – a ca se r ep or t (P re m as iri a nd Ed iri w ee ra 2 01 8) G oy uk ol a (C en te lla as ia tic a) N as ya + Th ila di le pa pa st e (S es am um in di cu m m ix ed w ith li m e ju ic e) A cn e Sk in A yu rv ed a A c om pa ra tiv e st ud y on t he e ff ec t an d ef fic ac y of m as ha ba la di d ec oc tio n or al an d m as ha ba la di d ec oc tio n na sy a fo r gr iv as an dh ig at av at a (c er vi ca l s po nd yl os is ) (P riy ad ar sh an i a nd Sa m ar ak oo n, 2 01 7) D ec oc tio n C er vi ca l sp on dy lo si s M us cu lo sk el et al A yu rv ed a A c om pa ra tiv e cl in ic al s tu dy o n th e ef fe ct o f Bh un im bh ad i A sh ta da sh an ga d ec oc tio n an d D ha ny ak a Sh un ti de co ct io n on v at aj ah rid ro ga (is ch ae m ic h ea rt d is ea se ) (P riy ad ar sh an i, 20 16 ) D ec oc tio n H ea rt d is ea se C ar di ov as cu la r A yu rv ed a C lin ic al e va lu at io n of t he e ff ic ac y of Pr at hi sa ra ne ey a K sh ar a in t he m an ag em en t of ha em or rh oi ds (R aj ap ak se , 2 01 8) K sh ar a ap pl ic at io n H ae m or rh oi ds C ar di ov as cu la r A yu rv ed a 37A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e Th e ef fic ac y of t he E ra nd as ap ta ka pa nt ai n th e m an ag em en t of K as ht ar ta va (R an at hu ng a, 2 01 6) H er ba l t ea M en st ru at io n sc an ty Fe m al e ge ni ta l A yu rv ed a A c om pa ra tiv e cl in ic al s tu dy o n th e ef fe ct o f Tr ip al ad i d ec oc tio n & P at ol ad i d ec oc tio n on am la pi tt a (R an aw ee ra , 2 01 6) D ec oc tio n G ER D D ig es tiv e A yu rv ed a A c om pa ra tiv e cl in ic al s tu dy o n th e ef fe ct o f Ph al at hr ik ad i a nd H em ad ru m as ya di d ec oc tio ns on A pa th ya N im itt aj a Pr am eh a (t yp e II D M ) (R at na ya ke , 2 01 6) D ec oc tio n D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a Ef fic ac y of A eg le m ar m al oe s ha lf rip e fr ui t ju ic e in d ys en te ry – a c as e st ud y (R ay ee za , 2 01 6) H er b D ys en tr y D ig es tiv e A yu rv ed a A yu rv ed a tr ea tm en t re gi m e in t he m an ag em en t of G ui llo n- Ba rr é sy nd ro m e: A ca se s tu dy (R is m iy a, 2 01 8) H er b G ui lla in -B ar ré sy nd ro m e N eu ro lo gi ca l A yu rv ed a Pr el im in ar y ca se s tu dy o n ty pe 2 d ia be te s m el lit us (R iz w an a an d H af ee l, 20 17 ) H er b D ia be te s En do cr in e/ m et ab ol ic a nd N ut rit io na l A yu rv ed a M an ag em en t of M ur iv u N er iv u by t ra di tio na l ph ys ic ia n (S ab es an , A jil a et a l. 20 15 ) H er b M ur iv un er iv u (f ra ct ur e an d di sl oc at io n) A yu rv ed a A c om pa ra tiv e st ud y of t he e ff ec t of K sh ar su tr a Ba nd ha n (li ga tio n) w ith r ub be r ba nd li ga tio n in t he m an ag em en t of a rs ha (h ae m or rh oi ds ) (S ah av e, 2 01 5) K sh ar a ap pl ic at io n H ae m or rh oi ds C ar di ov as cu la r A yu rv ed a A c as e st ud y on Z of -e -In tis ha r (e re ct ile dy sf un ct io n) w ith a U na ni e xt er na l a pp lic at io n (S aj a, 2 01 5) To pi ca l ap pl ic at io n Im po te nc e M al e ge ni ta l U na ni A c om pa ra tiv e cl in ic al s tu dy o n th e ef fic ac y of Si nh as ya di a nd C hi nn od bh aw ad i d ec oc tio ns o n A m la pi tt a (G ER D ) (S am ar as in gh e K A A L, 20 16 ) D ec oc tio n G ER D D ig es tiv e A yu rv ed a 38 A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e A c as e st ud y on li po m a w ith Ir sa l-e -A la q (le ec h th er ap y) (S am iy a, 2 01 5) Le ec h th er ap y Li po m a Sk in U na ni Ef fe ct o f tr ad iti on al m ed ic at ed p as t an d O th iy am P ad da i T ha ila m o n fr ac tu re – a c as e st ud y (S ar an ya a nd G ow ri, 20 17 ) To pi ca l ap pl ic at io n Fr ac tu re M us cu lo sk el et al Si dd ha A c om pa ra tiv e ef fe ct iv en es s of A pa m ar ga th ik sh na ks ha ra a pp lic at io n an d sc le ro th er ap y in t he m an ag em en t of a rs ha (f irs t-a nd s ec on d- de gr ee p ile s) : P IL O T st ud y (S ha h, 2 01 8) K sh ar a ap pl ic at io n H ae m or rh oi ds C ar di ov as cu la r A yu rv ed a Ef fic ac y of U na ni m an ag em en t m od al iti es in co ng en ita l h yp ot hy ro id is m – a c as e st ud y (S hi fr a, 2 01 7) H er b H yp ot hy ro id is m En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a To pi ca l a pp lic at io n of p as te o n cu ta ne ou s co rn s in s ol e – ca se s tu dy (S hi ya m al a an d V ar na ku le nd ra n, 2 01 7) To pi ca l ap pl ic at io n C or n Sk in A yu rv ed a Ef fic ac y of c om bi ne d ru g th er ap y on c ar pa l tu nn el s yn dr om e (S hi ya m al a , 2 01 5) H er b C ar pa l t un ne l sy nd ro m e N eu ro lo gi ca l A yu rv ed a C lin ic al s tu dy o f th e U na ni c om po un d m ed ic al pr ep ar at io n fo r an til ip id ae m ic a ct iv ity in hy pe rli pi da em ic p at ie nt s (S ira ju de en , 2 01 6) H er b D is lip id em ia En do cr in e/ m et ab ol ic a nd nu tr iti on al U na ni A c om pa ra tiv e st ud y of t he e ff ic ac y of A rk a (C al ot ro pi sg ig an tia ) an d A pa m ar ga (A ch yr at hu sa sp er a) p ra th is ar an ee ya ks ha ra in th e m an ag em en t of p itt aj aa rs ha (S ol oh ok ar a, 2 01 8) K sh ar a ap pl ic at io n H ae m or rh oi ds C ar di ov as cu la r A yu rv ed a Ev al ua tio n of t he t he ra pe ut ic e ff ec t of “V ar ak ad id ec oc tio n” o n m ad hu m eh a (d ia be te s m el lit us ) – A c as e st ud y (S ri K an th i, 20 16 ) D ec oc tio n D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a/ In di ge no us m ed ic in e A s tu dy o n no n- m ed ic in al m an ag em en t of ce rv ic al s po nd yl os is (S riv as ta va P ra sa d an d A tu l, 20 17 ) To pi ca l ap pl ic at io n C er vi ca l sp on dy lo si s M us cu lo sk el et al A yu rv ed a 39A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e Th e ef fe ct o f m ed ita tio n in in so m ni a du e to st re ss : A c as e st ud y (S uj ee th as i, 20 18 ) M ed ita tio n In so m ni a Sl ee p di st ur ba nc e Sp iri tu al /A yu rv ed a Th e as se ss m en t of c ur in g ef fe ct o f N ee liy at hi th ai la m o n th os e af fe ct ed b y da nd ru ff (T hi la ge sw ar y an d V as an th y, 2 01 6) To pi ca l ap pl ic at io n D an dr uf f Sk in A yu rv ed a Th e ef fe ct iv en es s of N ee ly ad io il lo ca l ap pl ic at io n in r ec ov er y of p ar tia l f is tu le to m y fo llo w ed b y ks ha ra su tr a th er ap y – a ca se s tu dy (T hi la k, S w ap na a nd K um ar a, 2 01 7 To pi ca l ap pl ic at io n Fi st ul a Sk in A yu rv ed a Th e “O th iy am pa dd ai pa th th u” in B ox er ’s fr ac tu re m an ag em en t at r ur al A yu rv ed ic ho sp ita l P an da te ru pp u, J af fn a (T hi le eb an , 2 01 5) To pi ca l ap pl ic at io n Fr ac tu re M us cu lo sk el et al Si dd ha A ss es sm en t of t ra di tio na l t re at m en t m od al ity in t he m an ag em en t of a de no ca rc in om a of pr os ta te : A c as e re po rt b as ed o n cy to ki ne ex pr es si on (U m ay an ga ni 2 01 8) H er b C an ce r( pr os ta te ) M al e ge ni ta l A yu rv ed a/ In di ge no us m ed ic in e A ss es sm en t of e ff ec tiv en es s of t re at m en t m od al ity in t he m an ag em en t of a va ba hu ka (f ro ze n sh ou ld er )/ ca se s tu dy (U m ay an ga ni , 2 01 5) H er b Fr oz en s ho ul de r M us cu lo sk el et al A yu rv ed a S. a nd a ss es sm en t of t he A yu rv ed ic /t ra di tio na l tr ea tm en t re gi m en in a de no ca rc in om a of pr os ta te – c as e se rie s re vi ew (U m ay an ga ni , Ja ya th ila ke e t al . 2 01 7) H er b C an ce r (p ro st at e) M al e ge ni ta l A yu rv ed a Ro le o f tr ad iti on al p ra ct iti on er s on t re at in g ve rt eb ra l l es io n ca us ed b y tr au m a – a ca se st ud y (U th ay ak um ar , 2 01 6) H er b Fr ac tu re M us cu lo sk el et al A yu rv ed a “A da th od ai K ud in ee r” – p ot en tia lly p ol yh er ba l Si dd ha f or m ul at io n fo r m an ag em en t of br on ch ia l a st hm a (U tt ay am , 2 01 4) H er b A st hm a Re sp ira to ry Si dd ha 40 A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e Ef fe ct iv en es s of K ov ai ki zh an gu ch oo ra na m f or th e m an ag em en t of m at hu m eg am (V ar un a, 2 01 6) H er ba l p ow de r D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al Si dd ha Th e ef fe ct o f Ro ga ni kh as h, s un lig ht s oa p an d C hu na m p as te f or “ K ad ar a” a s an e xt er na l ap pl ic at io n – A c as e st ud y (W ee ra se ka ra , 2 01 5) To pi ca l ap pl ic at io n C or n Sk in A yu rv ed a/ In di ge no us m ed ic in e Ev al ua tio n of t he t he ra pe ut ic e ff ec t of A yu rv ed ic h er bo -m in er al f or m ul at io n C ha nd ra pr ab ha va ti on m eh a – A c as e st ud y (W ee ra se ka ra , 2 01 6) H er ba l p ill s D ia be te s En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a C lin ic al e xp er ie nc es in m an ag em en t of hy pe rli pi da em ia a nd is ch ae m ic h ea rt d is ea se (I H D ) by m ea ns o f po ly he rb al f or m ul at io ns (P F) : C as e se rie s (W el iv ite go da e t al ., 20 17 ) H er b IH D C ar di ov as cu la r A yu rv ed a St ud y th e ef fic ac y of li ne o f tr ea tm en t fo r ch ro ni c w ou nd w ith c el lu lit is b y m ea ns o f in di ge no us m ed ic in e: A c as e re po rt (W el iv te go da , 2 01 8a ) H er b C el lu lit is Sk in A yu rv ed a/ In di ge no us m ed ic in e Ef fe ct iv e A yu rv ed a tr ea tm en t re gi m e on D us ht a V ra na – A c as e st ud y (W ic kr am as in gh e an d Sa ku nt ha la H er b U lc er Sk in A yu rv ed a Ef fic ac y of in di ge no us t re at m en t re gi m e on M an da m in S ri La nk a – ca se s er ie s (W ic kr am as in gh e, A lu po th ak um bu ra , a nd Sa ku nt ha la , 2 01 7) H er b In di ge st io n D ig es tiv e A yu rv ed a/ In di ge no us m ed ic in e H ep at iti s B pa tie nt m an ag em en t th ro ug h U na ni m ed ic in e – a ca se s tu dy (Z ai di , 2 01 6) H er b H ep at iti s H ep at iti s U na ni K at up ila ( Se cu rin eg al eu co py ru s) a s a po te nt ia l op tio n fo r di ab et ic w ou nd m an ag em en t (A jm ee r, D ud ha m al , G up ta , & M ah an ta , 20 14 ) To pi ca l ap pl ic at io n D ia be te s A yu rv ed a Py od er m an g an gr en os um t re at ed w ith M ar ha m -e -r aa l – a c as e se rie s (A hm ad , A la m , & D an dr oo , 2 01 7) H er b Sk in d is ea se Sk in U na ni 41A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e C as e st ud y on a ct in om yc os is (K ak an an tik ak us ht a) (B M A RI , 2 01 7a ) H er b Ba ct er ia l in fe ct io n M us cu lo sk el et al A yu rv ed a C lin ic al e ff ec t of S ep al ik a (N yc an th es ar bo rt ris tis ) N iru ha V as ti, S ep al ik a Su du lu nu K as ha ya a nd L ak sh ad ile pa o n G ru dh ra si ( sc ia tic a) – A c as e st ud y (E . E di ris in gh e, Ed iri w ee ra , & W ee ra si ng he , 2 01 8) En em a + de co ct io n Sc ia tic a M us cu lo sk el et al A yu rv ed a Ef fe ct o f Sa pa V ire ka C ho or na o n V ib an dh a (m al a ad as si ya /c hr on ic c on st ip at io n) – s er ie s of c as e st ud ie s (E E di ris in gh e, Ed iri w ee ra , & D ha m as iri , 2 01 9) H er ba l p ow de r C on st ip at io n D ig es tiv e A yu rv ed a Ef fe ct o f Sr i L an ka n tr ad iti on al m ed ic in e Ja th ip ha la ad i L ep a an d H ee n D em at a Y us ha N as ya o n m an ib an dh as ho ol a [c ar pa l t un ne l sy nd ro m e] – a c as e re po rt (L an ka ni & E di ra w ee ra , 20 18 ) N as ya + t op ic al ap pl ic at io n C ar pa l t un ne l N eu ro lo gi ca l A yu rv ed a/ In di ge no us m ed ic in e A c lin ic al s tu dy o n ef fic ac y of S iy ak ka i ( A ca ci a co nc in na ) ha ir w as h on D ar un ak a (P ity ria si s ca pi tis ) (E di ra w ee ra , 2 02 1) H er ba l h ai rw as h Ti ne a Sk in A yu rv ed a Ef fe ct o f V am an a K ar m a, T rip ha la K as ha ya an d D eh ig et ad i L ep a in t re at m en t of k iti bh a (p so ria si s) – a c as e st ud y (J ay as ek ar a & Ed ira w ee ra , 2 01 9) D ec oc tio n + to pi ca l ap pl ic at io n Ps or ia si s Sk in A yu rv ed a Pr in ci pl es o f tr ad iti on al m ed ic in e in t he m an ag em en t of c an ce r – a ca se r ep or t (J ay as un da ra , G un th ila ka , & P er er a, 20 14 ) D ec oc tio n + he rb - m in er al d ru gs C an ce r C an ce r In di ge no us m ed ic in e Th er ap eu tic e ff ec ts o f Sr i L an ka n A yu rv ed a tr ea tm en t re gi m en s fo r ut er in e fib ro id s – a ca se s er ie s (E Pr iy ad ar sh an i, K ar un ag od a, & P er er a, 20 16 ) H er b U te rin e fib ro id s Pr eg na nc y, ch ild be ar in g, fa m ily p la nn in g A yu rv ed a A c lin ic al s ur ve y on e ff ec t on m at er na l s tr es s du rin g pr eg na nc y fo r au tis tic d is or de rs (L ee na , 2 01 8) A ut is m Pr eg na nc y, ch ild be ar in g, fa m ily p la nn in g A yu rv ed a 42 A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e A ss es si ng t he t he ra pe ut ic e ff ec t of K ak ul u ric e flo ur ( K RF ) pa st e fo r ca rp al t un ne l s yn dr om e (M en di s, W ije si ng he , & A tt an ay ak e, 2 01 7) H er ba l p as te C ar pa l t un ne l N eu ro lo gi ca l A yu rv ed a Sr i L an ka n tr ad iti on al V ire ch an a K ar m a w ith Eh el a Pe ni ( C as si a fis tu la ) an d ap pl ic at io n of K al uw al a A le pa ( A lp in ia m al ac ce ns is ) in t re at m en t of s id hm ak us ht a (p ity ria si s ve rs ic ol or ) – a ca se s tu dy (N av od i, Ed iri w ee ra , & K um ar a, 2 01 7) Pu rg at io n (V ire ka ) + to pi ca l ap pl ic at io n Pi ty ria si s ve rs ic ol or Sk in A yu rv ed a/ In di ge no us m ed ic in e Ef fe ct s of D ha ny am la pa ris he ka in t he m an ag em en t of A m av at a w ith s pe ci al re fe re nc e to r he um at oi d ar th rit is – a c as e st ud y (R . R an as in gh e, Ed iri w ee ra , & O ff ic er , 20 15 ) D ha ny am la de co ct io n + Pa ra sh ek a Rh eu m at oi d ar th rit is M us cu lo sk el et al A yu rv ed a Ef fe ct o n A gn i i n m an ag em en t of c an ce r: a ca se s tu dy o f A yu rv ed ic p er sp ec tiv e (V S en ev ira tn e, P er er a, & S D , 2 01 4) H er b C an ce r C an ce r A yu rv ed a Ef fic ac y of U na ni m an ag em en t m od al iti es in co ng en ita l h yp ot hy ro id is m – a c as e st ud y (S hi fr a, 2 01 7) U na ni h er b H yp ot hy ro id is m En do cr in e U na ni Ef fe ct o f Ra kt ha m ok sh an a (b lo od -le tt in g th er ap y) a nd S ri La nk an t ra di tio na l m ed ic in e on s ira ja gr an th i ( va ric os e ve in s) – a c as e st ud y (M . W ic kr am as in gh e & Ed iri w ee ra , 2 01 8) Bl oo dl et tin g V ar ic os e ve in s C ar di ov as cu la r A yu rv ed a Ef fic ac y of ja w ar is h- e- ka m oo ns aa da in t he m an ag em en t of c om m on g as tr oi nt es tin al co m pl ai nt s: A c lin ic al s tu dy (S ilm iy a, 2 01 5) H er b D ig es tiv e di so rd er D ig es tiv e U na ni Th er ap eu tic e ff ec t of A yu rv ed a tr ea tm en t re gi m en s fo r su bf er til ity – c as e se rie s (B M A RI , 2 01 7g ) H er b Fe rt ili ty Pr eg na nc y, ch ild be ar in g, fa m ily p la nn in g A yu rv ed a A c lin ic al e va lu at io n of t rip ha la ch ur na in t he m an ag em en t of m ed or og a (h yp er lip id ae m ia an d ob es ity ) (S . J ay as in gh e, 2 01 5) H er ba l p ow de r O be si ty En do cr in e/ m et ab ol ic a nd nu tr iti on al A yu rv ed a 43A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e A c as e st ud y on t he m an ag em en t of o bs es si ve - co m pu ls iv e di so rd er w ith s pe ci al r ef er en ce t o Bu to nm ad a (R . L iy an ag e, 2 01 8) H er b O C D Ps yc ho lo gi ca l A yu rv ed a Ef fe ct o f Sr i L an ka n tr ad iti on al m ed ic in e an d A yu rv ed a on s an dh ig at av at a (o st eo ar th rit is o f kn ee jo in t) (P . K . P er er a, P er er a, & K um ar as in gh e, 2 01 4) H er b O st eo ar th rit is M us cu lo sk el et al A yu rv ed a Tr ad iti on al S ri La nk an m ed ic in e in te rv en tio n in t he m an ag em en t of k ne e os te oa rt hr iti s (ja nu sa nd ig at av at a) : C as e se rie s (P P er er a & K um ar as in gh e, 2 01 8) H er b O st eo ar th rit is M us cu lo sk el et al A yu rv ed a/ In di ge no us m ed ic in e A c lin ic al s tu dy o n th e m an ag em en t of Sa nd hi ga ta va ta : A c as e st ud y (J ay as en a, 2 01 8) H er b O st eo ar th rit is M us cu lo sk el et al A yu rv ed a C lin ic al e va lu at io n of a s el ec tiv e tr ea tm en t re gi m e on s an dh ig at a- va ta (J . J ay as in gh e, K ul at un ga , & M ad us ha ni , 2 01 8) H er b O st eo ar th rit is M us cu lo sk el et al A yu rv ed a Ef fic ac y of a cu pu nc tu re o n os te oa rt hr iti s of kn ee jo in t: A c as e re po rt (G am ag e, 2 01 8) A cu pu nc tu re O st eo ar th rit is M us cu lo sk el et al A yu rv ed a Th er ap eu tic e ff ic ac y of J an u V as ti an d th e tr ad iti on al lo ca l a pp lic at io n in t he m an ag em en t of s an dh ig at av at a (o st eo ar th rit is ) (J ay aw ar dh an e, 2 01 6) To pi ca l ap pl ic at io n + Ja nu V as ti O st eo ar th rit is M us cu lo sk el et al A yu rv ed a Th er ap eu tic e ff ec ts o f Sr i L an ka n tr ad iti on al m ed ic in e an d ay ur ve da t re at m en t re gi m es on S an dh ig at ha V at a (o st eo ar th rit is ) – a ca se se rie s (A . P er er a, 2 01 5) H er b O st eo ar th rit is M us cu lo sk el et al In di ge no us m ed ic in e C as e st ud ie s w ith s el ec te d tr ea tm en t re gi m en in t he m an ag em en t of s an dh ig at av at a (o st eo ar th rit is ) (S ew w an di , 2 01 5) H er b O st eo ar th rit is M us cu lo sk el et al A yu rv ed a C lin ic al e va lu at io n of S hi ro dh ar a an d M at ra V as ti w ith B al ad i Y og a on f at ig ue a ft er s tr ok e (p ak sh ag ha ta ) (D . S ilv a, 2 01 5) En em a + Sh iro dh ar a Pa ra ly si s N eu ro lo gi ca l A yu rv ed a 44 A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e Im pr ov em en t of c er ta in h ae m at ol og ic al v al ue s in a p at ie nt w ith p ol yc yt he m ia ( ru br a) v er a fo llo w in g A yu rv ed a tr ea tm en t: A c as e re po rt (P er er a, 2 01 5a ) H er b Po ly cy th em ia ve ra Bl oo d, b lo od - fo rm in g or ga ns an d im m un e m ec ha ni sm A yu rv ed a Ro le o f Sh at av ar i K sh ee ra B as ti in t he m an ag em en t of G ha rb ha K sh ay a (I U G R) , a c as e st ud y (S aj ee w an i, 20 15 ) En em a Pr eg na nc y di so rd er Pr eg na nc y, ch ild be ar in g, fa m ily A yu rv ed a M an ag em en t of b en ig n pr os ta tic h yp er pl as ia – an A yu rv ed ic a pp ro ac h (D w iv ed i, 20 16 ) H er b Pr os ta te hy pe rp la si a M al e ge ni ta l A yu rv ed a A p re lim in ar y st ud y on p re va le nc e of pr ot ei nu ria a nd a bn or m al s er um c re at in in e le ve ls a m on g th e pa tie nt s at te nd ed f or A yu rv ed a tr ea tm en ts (B M A RI , 2 01 7f ) H er b Pr ot ei nu ria U ro lo gi ca l A yu rv ed a Im pa ct o f cl in ic al ly e ff ec tiv e A yu rv ed a tr ea tm en t on li ve r an d ki dn ey f un ct io ns o f ps or ia si s pa tie nt s (B M A RI , 2 01 7e ) H er b Ps or ia si s Sk in A yu rv ed a A c lin ic al s tu dy o f V ire ch an a K ar m a w ith D im or ph oc al yx gl ab el lu s de co ct io n of va sa gu du ch ya di ya a nd a ni th th ad ile pa in t he m an ag em en t of p so ria si s (B M A RI , 2 01 7d ) D ec oc tio n Ps or ia si s Sk in A yu rv ed a C lin ic al s tu dy o f N im ba di le pa w ith p in da o il in t he m an ag em en t of t hi ck ne ss c on di tio n of si dh m a K us ht a (p so ria si s) (B M A RI , 2 01 7c ) To pi ca l ap pl ic at io n Ps or ia si s Sk in A yu rv ed a A n ob se rv at io na l s tu dy o n th e th er ap eu tic ef fe ct o f po ly he rb al f or m ul a in t he m an ag em en t of ( D aa u s Sa da f) p so ria si s vu lg ar is (A . F az ee na h, 2 01 6) H er b Ps or ia si s Sk in U na ni 45A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e C as e re po rt o n m an ag em en t of k us ht a (p so ria si s) w ith V ire ch an a K ar m a (in du ce d pu rg at io n) a nd R as ay an a (r ej uv en at io n) th er ap y (M ah es h, Pa ra pp ag ou dr a, & N av od ay ra ju , 2 01 7) Pu rg at io n (v ire ka ) + re ju ve na tio n (r as ay an a th er ap y) Ps or ia si s Sk in A yu rv ed a A s tu dy o n th e ef fic ac y of t ra di tio na l s hi ro le pa in t he m an ag em en t of s ca lp p so ria si s (P ra m od an i, 20 15 ) To pi ca l ap pl ic at io n Ps or ia si s Sk in A yu rv ed a A c om pa ra tiv e cl in ic al e va lu at io n of V as ag ud uc hy ad i d ec oc tio n an d A ni th th ad iL ep aw ith a nd w ith ou t V ire ch an a K ar m a w ith W el iw en na in t he m an ag em en t of ki tib ha ( ps or ia si s) (D ew an ar ay an a, 2 01 5) D ec oc tio n + to pi ca l ap pl ic at io n Ps or ia si s Sk in A yu rv ed a Ef fe ct o f un m ad ag aj ak es ar ira sa o n A st av id ha M an ob ha va s of k ap ha ja un m ad a (A riy ar at ne , 2 01 6) H er ba l p ill s Ps yc ho lo gi ca l di so rd er Ps yc ho lo gi ca l A yu rv ed a Ef fe ct o f un m ad ag aj ak es ar ira sa o n ka ph aj au nm ad am a (A riy ar at ne , 2 01 5) H er ba l p ill s Ps yc ho lo gi ca l di so rd er Ps yc ho lo gi ca l A yu rv ed a Ef fe ct iv en es s of N av ar ak iz hi o n Si th P er al um U m at hu w a (C . L iy an ag e, 2 01 5) To pi ca l ap pl ic at io n Ps yc ho lo gi ca l di so rd er Ps yc ho lo gi ca l A yu rv ed a/ In di ge no us m ed ic in e C as e st ud y on z oa f- e- ku ly a (r en al f ai lu re ) (R ae su dd ee n, 2 01 5b ) Re na l f ai lu re U ro lo gi ca l U na ni Th er ap eu tic p ot en tia ls o f D ha ny am la (a f er m en te d ce re al ) ag ai ns t A m av at a (P . R an as in gh e, 2 01 8) H er b Rh eu m at oi d ar th rit is M us cu lo sk el et al A yu rv ed a C om pa ra tiv e ev al ua tio n of D ha ny am la V as ti an d K ay as ek a in t he m an ag em en t of A m av at a W sr t o rh eu m at oi d ar th rit is (P . R an as in gh e, 2 01 5) En em a + de co ct io n Rh eu m at oi d ar th rit is M us cu lo sk el et al A yu rv ed a C lin ic al s tu dy o n Ba la K or an da T ai la ( BK T) m at ra va st i a nd E ra nd a Sa pt ak a K as ha ya ( ES K ) in t he m an ag em en t of g rid ra si (N is hs ha nk a, 2 01 6b ) To pi ca l ap pl ic at io n Sc ia tic a M us cu lo sk el et al A yu rv ed a 46 A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e A c om pa ra tiv e cl in ic al s tu dy o n th e ef fe ct of C hi tr ak ad i o il m at ra va st i a nd S in ha sy ad i de co ct io n or al ly in t he m an ag em en t of gr id hr as i ( sc ia tic a) (V id an ap at hi ra na , 20 16 ) D ec oc tio n + to pi ca l ap pl ic at io n Sc ia tic a M us cu lo sk el et al A yu rv ed a C lin ic al s tu dy o n Er an da sa pt ak ak as ha ya in t he m an ag em en t of g rid ra si (N is hs ha nk a, 2 01 6a ) D ec oc tio n Sc ia tic a M us cu lo sk el et al A yu rv ed a A c as e st ud y on D a ul F aq aa ( Pe m ph ig us vu lg ar is ) (S al m a, 2 01 5) Sk in d is ea se Sk in U na ni Se le ct iv e A yu rv ed a tr ea tm en t m od al ity f or Li ch en P la nu s (v is ha ja ku sh ta ) – a ca se s tu dy (P er er a, D is sa na ya ke , & Ja ya ko dy , 2 01 7) H er b Sk in d is ea se Sk in A yu rv ed a Ef fe ct o f Ro gh an e k ha s on o ve rg ra nu la tio n tis su e fo rm at io n in p os t-e pi si ot om y w ou nd – a ca se s tu dy (M us m ira , 2 01 5) To pi ca l ap pl ic at io n Sk in d is ea se Sk in A yu rv ed a Su cc es sf ul A yu rv ed ic t re at m en t m od al ity f or Pr ur ig o no du la ris ( ty pe o f vi sh aj ak us ht a) – a ca se s tu dy (P er er a, 2 01 5b ) H er b Sk in d is ea se Sk in A yu rv ed a D ev el op m en t of a s ub st itu te o il fo r V ip ad ik ah ar a G rit a Ta ila a nd it s ev al ua tio n ag ai ns t V ip ad ik a sk in d is ea se ( a ca se s tu dy ) (H ew ag ee ga na , 2 01 5) To pi ca l ap pl ic at io n Sk in d is ea se Sk in A yu rv ed a A s uc ce ss fu l p re gn an cy o ut co m e af te r re pe at ed s po nt an eo us a bo rt io n du e to m yo m a (S al a’ el ai fiy a) – a ca se r ep or t (F ar za na , 2 01 5) H er b Sp on ta ne ou s ab or tio n Pr eg na nc y, ch ild be ar in g, fa m ily U na ni A c om pa ra tiv e cl in ic al s tu dy t o ev al ua te th e ef fe ct iv en es s of n ya gr od ha di le pa a nd m an jis th ad ile pa o n an kl e sp ra in : A c as e st ud y (M eh er & G op ik ris hn a, 20 17 ) To pi ca l ap pl ic at io n Sp ra in M us cu lo sk el et al A yu rv ed a Th e V ar m a th er ap y m an ag em en t fo r su lu kk u (s pr ai n) (N ith ya pr iy a, 2 01 5) H er b Sp ra in M us cu lo sk el et al A yu rv ed a 47A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e C as e se rie s on e ff ec t of A yu rv ed ic t re at m en t re gi m en s fo r va nd ya th va ( su bf er til ity ) (J . J ay as in gh e, 2 01 5) H er b Su bf er til ity Pr eg na nc y, ch ild be ar in g, fa m ily p la nn in g A yu rv ed a A c lin ic al e va lu at io n of t he e ff ec t of Sh ot ha ha ra c om po un d on S ho th a (K um ar i, 20 15 b) To pi ca l ap pl ic at io n Sw el lin g G en er al a nd un sp ec ifi ed A yu rv ed a C as e st ud y on s yn ov iti s (R ae su dd ee n, 2 01 5a ) H er b Sy no vi tis M us cu lo sk el et al A yu rv ed a C lin ic al s tu dy o n be ej ad us ht ija ny ap an du (t ha la ss em ia m aj or ) in c hi ld re n an d its m an ag em en t w ith M us ta -t hr ip ha la di av al eh a an d G an dh ak ad i y og a (K al aw an a, 2 01 8) H er ba l p as te + yo ga Th al as se m ia Bl oo d, b lo od - fo rm in g or ga ns an d im m un e m ec ha ni sm A yu rv ed a A p re lim in ar y st ud y on lo ca l e ff ec t of tr ad iti on al h er ba l r em ed y us ed in t ra um at ic n ai l in ju rie s (K ar un ar at hn a, 2 01 6) To pi ca l ap pl ic at io n Tr au m at ic n ai l G en er al a nd un sp ec ifi ed A yu rv ed a/ In di ge no us m ed ic in e C lin ic al e va lu at io n of s iv ap pu ku ki lth ai la pa st e w ith p an ch at hu va rp ik as ay am in t he m an ag em en t of w ou nd (R aj ee v, 2 01 6) To pi ca l ap pl ic at io n U lc er Sk in A yu rv ed a Ef fe ct o f le ec h th er ap y on d ia be tic f oo t ul ce r – a ca se s tu dy (G un ar at hn a, 2 01 6) Le ec h th er ap y U lc er Sk in A yu rv ed a C as e st ud y on K sh ar a ap pl ic at io n in d ia be te s fo ot u lc er (S am ar an ay ak e & Pu sh pa ku m ra , 2 01 7) K sh ar a ap pl ic at io n U lc er Sk in A yu rv ed a M an ag em en t of u ro lit hi as is w ith r ef er en ce t o A yu rv ed ic c on ce pt s: A c as e st ud y (P at hi ra na , 2 01 8) H er b U ro lit hi as is U ro lo gi ca l A yu rv ed a Th er ap eu tic e ff ec ts o f Sr i L an ka n A yu rv ed a tr ea tm en t re gi m es f or u te rin e fib ro id s – a ca se se rie s (E P riy ad ar sh an i, 20 15 ) H er b U te rin e fib ro id Fe m al e ge ni ta l A yu rv ed a Pe ss ar y tr ea tm en t fo r ut er in e pr ol ap se a nd he al th -re la te d qu al ity o f lif e: A c as e st ud y (R um ai za , 2 01 6) Pe ss ar y U te rin e pr ol ap se Fe m al e ge ni ta l A yu rv ed a 48 A review of traditional medicine research in Sri Lanka: 2015–2019 St u d y ti tl e A u th o r/ Y ea r In te rv en ti o n 1 C o n d it io n IC PC *t it le TM t yp e W ou nd -h ea lin g ef fe ct o f tr ad iti on al h er ba l fo rm ul at io n (P ac hc he nn ai o il) o n va ric os e ul ce r (B M A RI , 2 01 7h ) To pi ca l ap pl ic at io n V ar ic os e ul ce r C ar di ov as cu la r Si dd ha A n A yu rv ed ic a pp ro ac h of c om pu te r vi si on sy nd ro m e an d m an ag em en t w ith T rip al a G hr it A ks hi th ar pa na : A c as e st ud y (K um ar ad ha rm as en a, 20 18 ) A ks hi Th ar pa na V is io n Ey e A yu rv ed a A yu rv ed ic m an ag em en t of m ac ul ar o de m a (A ks hi Ti m ira ): A c as e st ud y (S ur an gi , 2 01 8) A ks hi Th ar pa na V is io n Ey e A yu rv ed a A c as e st ud y on m an ag em en t of c hr on ic w ou nd w ith p ol yh er ba l f or m ul at io n (B M A RI , 2 01 7b ) H er b W ou nd h ea lin g Sk in A yu rv ed a Ef fe ct o f A yu rv ed ic t he ra pi es in t he m an ag em en t of in fe ct ed w ou nd s (S in g, 2 01 7) H er b W ou nd h ea lin g Sk in A yu rv ed a N ot es : * IC PC –W H O In te rn at io na l C la ss ifi ca tio n of P rim ar y C ar e 49A review of traditional medicine research in Sri Lanka: 2015–2019 Fig. 6. Overview of focus diseases conducted as case reports 0 5 10 15 20 25 30 Misc conditions <2 Skin conditions Fracture/Sprain Diabetes Haemorrhoids Women's health Kidney conditions Osteoarthrosis Obesity Digestive disorder Cardiovascular conditions Cancer Psychological disorder Ulcer Sciatica Fistula Wound healing Thyroid conditions Rheumatoid arthritis Frozen shoulder Cervical spondylosis Carpal tunnel Bacterial infection 3.3.6 Community-based health research and surveys Thirty-nine studies examining the community-based aspects of traditional medicine were identified. Some of these studies have attempted to collect data on knowledge, attitude and practice regarding Ayurveda treatments or specific diseases in relevant areas (Table 9). 50 A review of traditional medicine research in Sri Lanka: 2015–2019 Table 9. Community-based research Author* Research title Focus (BMARI, 2017a) Hospital-based study on knowledge, attitude and practice on dengue (includes findings on traditional medicine) Dengue (BMARI, 2017a) A survey on post-dengue complications (includes findings on traditional medicine) Dengue (BMARI, 2017a) Assessing the quality of life of diabetic patients following Ayurvedic treatments Diabetes (BMARI, 2017a) Distribution of Ayurveda medical centres for diabetes mellitus within central provinces Diabetes (BMARI, 2017a) Nutritional status of pre-school children in selected estates in Sri Lanka (includes findings on traditional medicine) Nutrition (BMARI, 2017a) Demographic characteristics of people who visit BMARI in 2013 according to ICD (International Classification of Disease) Population study on TM (Fatima, 2015) Evaluation of traditional food "Kitchadi" on weight gain among the pre-school children of four gravatte division in Galle Community study of TM (Fonseka, 2015) Role of diabetic retinopathy screening (includes findings on traditional medicine) Diabetes (Jayalal, 2015) Study on the need of stress management in Ayurveda health-care system in Sri Lanka Stress (Jayasinghe, Kulatunga, & Ratnapala, 2017) Identification of association between risk factors and serum cholesterol CVD risk factors (Kalyani, 2017) A study of dispensing Ayurvedic drugs on consumer satisfaction: Special reference to Puttalam district in Sri Lanka Herbal medicine regulation (Kavtiha, 2015) A study on lifestyle of elders in J/283 Gramaniladari division (idaikkadu), Sri Lanka (includes findings on traditional medicine) Lifestyle (Kumari, 2015a) An assessment of the perception of stress in type 2 diabetic patients in accordance with perceived stress scale (PSS 10) (includes findings on traditional medicine) Diabetes (Lakmali, 2015a) A study of clinical risk management in Ayurveda-teaching hospitals in Sri Lanka Safety (Ayurveda) (Lakmali, 2015b) A study of the factors influencing for the patterns of consumer behaviour in the medical sector (includes findings on traditional medicine) Drug safety (R. P. Liyanage, Hettige, & Karunarathne, 2017) Behavioural patterns of Ayurveda/traditional practitioners in diagnosis, treatment and referral of suspected leprosy patients to Western medical system Leprosy 51A review of traditional medicine research in Sri Lanka: 2015–2019 Author* Research title Focus (Loganathan, 2015) A study of distribution of “diagnosed hypertension” in Mathagal J/151 Grama Niladhari division from April to June 2012 (includes findings on traditional medicine) CVD risk factors (Munasinghe, 2015) ICS0 effect of obesity on quality of certain semen parameters of Sri Lankan male (includes findings on traditional medicine) Fertility (Nayanathara, 2015) Prevalence of risk factors for noncommunicable diseases in the selected population of urban areas in Thalawathuhenpita – North Grama Niladari divisions in Kelaniya district secretariat division of Gampaha district of Western Province, Sri Lanka and to develop a training programme with reference to Ayurveda medical system Education – Ayurvedic (Niranjan, 2015) A study of management practices for preventing noncommunicable diseases in elderly population in Trincomalee urban council area (includes findings on traditional medicine) Ageing (Nizamdeen, 2015) Prevalence of diabetes and impaired fasting glucose (IFG) in adult population in the Kadawath-sathara, Galle district (includes findings on traditional medicine) Diabetes (Pathiraja, 2017) The application of international human rights standards as a mechanism to protect the rights of the people living with HIV/AIDS: A Sri Lankan perspective HIV/AIDS (PK Perera, Silva, & Chandra, 2017) Health-seeking behaviour among patients with knee osteoarthritis in Sri Lanka Osteoarthritis (W. Perera, Perera, Ambagahawita, Wijesundara, & Bandaranayaka, 2018) People’s knowledge, attitude and practices towards dengue infection and prevention in a semi-urban area, Sri Lanka Dengue (Prashan, Kalpani, Pathirage, & Chathura, 2021) Knowledge and attitudes on first aid among GCE advanced level students in government schools of Gampaha education zone, Sri Lanka Medical knowledge (Priyadarshi, 2015) Application of Rasayana for paediatric population Lifestyle (Ralapanawa, Jayawickreme, Ekanayake, & Kumarasiri, 2016) A study on the knowledge and attitudes on advanced life support among medical students and medical officers in a tertiary care hospital in Sri Lanka Medical knowledge (Rathnakara, 2015) Prevalence of respiratory disorders of children, attending the Ayurveda Teaching Hospital, Colombo Respiratory (Samarakoon, 2015) A study on effective distribution of Ayurveda drugs in Eastern Province of Sri Lanka Rationale use of drug (Sandamali, 2015) Prevention of suicide (with especial reference to “sumithrayo” in Panduwasnuwara Western d.s. in Kurunegala District) Suicide 52 A review of traditional medicine research in Sri Lanka: 2015–2019 Author* Research title Focus (Silva & Thathparan, 2017) Analytical survey of patients attending to swithra (vitiligo) clinic Skin disease (Sivalathajini, 2015) Nutritional status survey among children in Sahayapuram, Jaffna, Sri Lanka (includes findings on traditional medicine) Nutrition (Stanieri et al., 2018) A visual grid to digitally record an Ayurvedic prakriti assessment; a first step toward integrated electronic health records Ayurvedic diagnosis (Thillany & Sathiyaseelan, 2015) Study on the dominance of Arogyam and intellectual activities in Guna changes among the elders in Shanthinilayam, Kaithady Ageing (Waratenne, 2015) A study of Sri Lankan cuisines with special reference to Ashtha Aaharavidhi Visheshayatana Ayurvedic nutrition (A. Wickramasinghe, 2015) Comprehensive survey of patients attending to the orthopaedic clinic in Ayurveda Teaching Hospital, Borella Musculoskeletal (Wijesinghe, Pilapitiya, Hettiarchchi, Wijerathne, & Siribaddana, 2017) Regulation of herbal medicine use based on speculation? A case from Sri Lanka Herbal medicine regulation (Wimalasooriya, 2016) Effect of an indigenous food supplement "Suwaposhini" on nutritional status of pre-school children in Galle district – a prospective community trial Community study of TM (Zabir, 2015) Knowledge, attitude and preventive measures of breast cancer among Maligawatta area women (includes findings on traditional medicine) Cancer Note: *Some of these studies were published as conference papers or posters during the review period and have since been published as research articles. Compared to case reports, 39 studies were undertaken during the review period in Sri Lanka, examining community behaviour, attitudes and practices around TM (Fig. 8). Some of these studies adhered to knowledge, attitudes and practices (KAP) and survey models. There were four (9.7%) studies, including two KAP studies and two survey-based studies, conducted on dengue fever. One (2%) KAP study was conducted on breast cancer among women. Five (12%) studies were conducted on diabetes, including one study on the quality of life (QOL) of patients and TM practices, two on prevalence studies of dengue fever, one on a diabetic retinopathy screening programme and one on stress and diabetes-based screening. Seven (17%) studies were nutritional status assessment surveys. One (2%) study was focused on prevalence of respiratory disorders among children. One study (2%) was conducted on the application of international human rights standards as a mechanism to protect the rights of the people living with HIV/AIDS from a Sri Lankan perspective. Two (5%) prevalence studies were conducted on musculoskeletal disorders, including osteoarthritis. Furthermore, two (5%) noncommunicable diseases-based survey studies were conducted during this period. 53A review of traditional medicine research in Sri Lanka: 2015–2019 One study collaborated with some of the Australian universities and published concept protocol to develop electronic health record (EHR) system through advanced prakriti-based phone app (187). The main contention advanced in this article is that Ayurvedic medicine can transition organically to be based on EHR, if the demand for electronic records is created by patients and clinicians. A model for this involves the use of an application accessible on smartphones. The app uses a visual triangle that enables a prakriti assessment to be readily entered and stored in a smartphone and shared with a patient. This first step has the potential to create a demand for the prakriti record to be expanded to include other health data and expanded again to enable records to be shared by many health-care providers. The model outlined presents an approach that facilitates the deployment of health record banks in a manner that may be affordable and sustainable. In our review of community-based studies, we found that several studies had utilized the KAP survey model. The model includes constructing survey protocol, preparing a survey, course of the KAP survey in the field, data analysis and presentation of the survey report, conclusion, references and abbreviations. In our analysis of these studies, we noted that the method of training of surveyor was not included in most of the studies. Fig. 7. Comparison of community-based health research and surveys conducted on different traditional medicine systems in Sri Lanka during 2015–2019* 0 10 20 30 40 Ayurveda/ Indigenous medicine Siddha Unani Note: *Some studies included more than one type of TM. Most of the community-based research on TM conducted in Sri Lanka focused on Ayurveda, compared to the Siddha and Unani systems of medicine (Fig. 7). 3.3.7 Summary of types of traditional medicine system research When comparing the types of research undertaken in traditional medicine, most of the research involves case studies and case series. There is a need to encourage researchers to publish their work in journals, which in turn makes their findings accessible to the community and other researchers. Nonetheless, these studies demonstrate a broad range of areas where TM in Sri Lanka has potential. 54 A review of traditional medicine research in Sri Lanka: 2015–2019 Fig. 9. Types of Ayurveda/TM research conducted during 2015–2019 77% 6% 1% 16% Case reports Clinical trials Systematic reviews Community based/surveys Of the 202 case reports, clinical trials and systematic reviews that have been completed and included in this review, 42 (21%) were conducted in the BMARI priority areas (Table 10). Diabetes garnered maximum focus. Table 10. Types of research conducted in the BMARI priority areas during 2015–2019 Cardiovascular disease Diabetes Kidney Cancer Dengue Total Case reports (n = 184) 7 13 9 6 1 36 (20%) Clinical trials (n = 13) 1 2 1 4 (31%) Systematic reviews (n = 3) 1 1 2 (67%) Total 8 (19%) 16 (38%) 9 (21%) 6 (14%) 3 (7%) 42 3.4 Discussions The TM research undertaken in Sri Lanka over the five-year period of this scoping review shows a developing research programme. While the largest number of studies involved case reports, some quality clinical trials had been undertaken and published in peer-reviewed journals. There is still considerable scope for improving these randomized controlled trials and seeking publication in journals that will have a higher impact. Some clinical trials did not appear to have progressed to publication beyond conference proceedings. These challenges are similar to those faced by reviews of studies registered on the Indian clinical trials registry (188) and reviews of studies published in Indian Ayurvedic journals (189). Ethics approval and subsequent registration with either SLCTR or ICRTN were the norms for most clinical trials. However, there were still some trials that were not registered on SLCTR and were only conducted with the approval received from institutional ethics review committees. There were two trials registered on the ICRTN registry for the first time (https://doi.org/10.1186/ISRCTN18149439, 55A review of traditional medicine research in Sri Lanka: 2015–2019 https://doi.org/10.1186/ISRCTN16108738). This is a key achievement to improve trial visibility. Several studies also had published clinical trial protocols. Clinical trial research can be improved considerably by encouraging the publication of research protocols such as that published by Dahanayake et al (2020). Traditional medicine clinical research in Sri Lanka is strongly supported by the education system and dedicated Ayurvedic hospitals The establishment of BMARI provides a strong focus for TM research. The research focus of BMARI on cardiovascular diseases, chronic kidney diseases, cancer and diabetes along with one communicable disease (dengue) is only somewhat apparent in the research output identified in this scoping review. Of the systematic reviews, clinical trials and case studies, only 21% were in the targeted research areas of BMARI. The predominance of musculoskeletal and skin condition case studies may reflect the high usage of traditional medicine for these conditions. There may be a need to draw more attention to the priority areas of BMARI, such as diabetes. A survey of diabetic patients visiting a Sri Lankan hospital found that 76% used some form of herbal medicine to reduce blood glucose (190). The registered clinical trials found were mainly Ayurvedic interventions, only some of the studies mentioned Ayurvedic outcomes. TM/Ayurveda treatment aims to achieve a balanced state of the doshas by treating the individual manifestation of a disease. Different manifestations require different treatments. Where a clinical trial is testing a fixed herbal formula, it may be anticipated that the formula may be more effective for certain dosha imbalances. Outcome measures for Ayurvedic effectiveness need to be considered in addition to conventional outcomes (191). Clinical trials are considered the main source of evidence-based medicine (EBM) and forms the backbone of clinical practice in any system of medicine. Evidence-based medicine categorizes different types of clinical evidence and ranks them according to the strength of their freedom from the various biases that beset medical research (192,193). Levels of evidence are provided to studies and they are ranked based on the methodological quality of their design, validity and applicability to patient care. These decisions provide the strength of recommendation (194) (see Table 11). Table 11. Levels of evidence Level of evidence (LoE) Description Level I Evidence from a systematic review or meta-analysis of all relevant RCTs (randomized controlled trials) or evidence-based clinical practice guidelines based on systematic reviews of RCTs or three or more RCTs of good quality that have similar results Level II Evidence obtained from at least one well-designed RCT (e.g. large multisite RCT) Level III Evidence obtained from well-designed controlled trials without randomization (i.e. quasi-experimental) Level IV Evidence from well-designed case-control or cohort studies Level V Evidence from systematic reviews of descriptive and qualitative studies (meta-synthesis) Level VI Evidence from a single descriptive or qualitative study Level VII Evidence from the opinion of authorities and/or reports of expert committees 56 A review of traditional medicine research in Sri Lanka: 2015–2019 The highest level of evidence is a meta-analysis where systematic reviews of several randomized controlled trials are analysed. Almost all Western countries apply EBM to the treatment of patients and this is supported by government guidelines and the pharmaceutical industry. EBM integrates individual clinical expertise and patient preferences with the best available external clinical evidence from systematic research (193). EBM evolved to respond to an increasing amount of research and to balance the use ofclinical expertise alone. EBMof Ayurveda/TM is difficult to practice without high-quality clinical trials and publications. Developing EBM in Ayurveda/TM empowers researchers and clinicians’ decision-making ability. Yet developing an EBM for Ayurveda, similar to other traditional forms of medicine, faces considerable challenges. This is perhaps one of the reasons why our review found a predominance of case reports rather than clinical trials. Case reports enable reporting of the treatment approach, Chikitsa sutra, applied to each disease, with variations for each individual. Traditional medicine systems classify drugs according to the Rasapanchaka (Ayurvedic pharmacology). The drug action is ascribed to certain attributes present in a drug, namely rasa (taste), guna (property), virya (potency), vipaka (post-digestive taste) and prabhava (effect) while in modern pharmacology, the drug action is attributed to the chemical structure of a molecule. The Rasapanchak modality can deliver treatment as it takes into consideration the prakriti of the person as well as the pharmacodynamics and pharmacokinetic properties of a drug, unlike in modern treatment which elicits varied response from person to person having the same drug for the same disease. The practice of a whole traditional medicine system and/or individualization is complex and poses challenges to research methods, particularly the dominant RCT design (195). Whereas a randomized controlled trial is considered the most appropriate research method, employing individualized or semi-standardized formulas or treatments could be considered. These methods have been developed for Chinese herbal medicine. In an individualized RCT, each participant is provided with an individualized prescription that may change over time and this is clearly documented in the study. Semi-standardized involves using a base treatment or formula that all participants receive but adjusting to the individual presentation (196). The dynamic therapeutic approach of Ayurveda and TM may render conventional research methods inappropriate. In such circumstances, the choice of study design should be discussed on a case-by-case basis with experts in fundamentals of CAM systems. Methodologies such as single-case design, black-box design and open-label design, and ethnographic and observational studies may be more appropriate for clinical research in instances where conventional RCTs could not be used in TM/Ayurveda (197). The taste and smell of Ayurveda drugs make it difficult to produce placebos This may be the reason why very few placebo control trials appeared. According to Ayurveda, taste (rasa) will have a particular effect on the body, which will contribute to healing. Hence, the same taste (rasa) in the placebo could also bring a similar effect to a certain extent. Hence, use of placebos 57A review of traditional medicine research in Sri Lanka: 2015–2019 and blinding are debatable with research that is planned in accordance with the fundamentals of TM/ Ayurveda approach. But 42% placebo control trials were conducted and 31% of the trials were double- blinded and 31% single-blinded in trials registered with WHO accepted trial registries in Sri Lanka. Traditional medicine indications were noted in the clinical trials and case reports, usually alongside a Western medicine term for the disease or condition. In general, for clinical trials, participants are selected according to standard diagnostic criteria for RCT and panchakarma therapies were few. However, some of these participants may not have been suitable for a standardized intervention, according to the principles of TM/Ayurveda, since TM/Ayurvedic treatment widely differs according to prakurthi, ama-nirama and the doshaja state. Case reports in our review included traditional panchakarma therapies whereas most clinical trials tended to revolve around oral herbal interventions only The case reports provide insight into the phenotypic features (prakriti) used in Ayurvedic medicine; these are not dissimilar to the genotypes that are increasingly being used in personalized medicine. The prakriti is used to determine the individualized or personalized treatment regime in Ayurveda. Similarly, the recent pharmacogenomics approach also targets patients according to their genotypes and RCTs have struggled to keep pace with this (198). Some published clinical trials included those on the adverse effect management system and data safety monitoring board (DSMB). Observational studies such as case reports in TM represent considerable effort and are an important source of data for future investigation. To maximize the potential of this research and ensure that researchers’ time and effort are well-invested, the use of internationally recognized standards for observational studies such as those developed by the EQUATOR network, The CARE Guidelines: Consensus-based Clinical Case Reporting Guideline Development, are recommended (199). This will facilitate the publication of case series and reports. The clinical trials and case reports show promising clinical outcomes. However, without an analysis of the quality of the trials and studies, no conclusions can be drawn. The Ayurvedic clinical trials for osteoarthritis and uterine fibroids warrant rigorous larger-scale studies. Ayurveda may provide a favourable treatment option for these conditions in contrast to invasive surgeries or hormone therapy. Other clinical trials have led to the development of consumer products such as herbal toothpaste and herbal cough syrup, and more recently, a treatment for fever. Other studies have demonstrated potential and may be suitable for development as commercial products, such as the anti-acne and memory booster/brain tonic products. Researchers may have focused on these diseases as conventional medicine has limited treatment options to manage conditions and/or Ayurveda therapy provides better efficacy and is more cost-effective when compared to conventional medicine. These research outcomes should be further analysed with extensive researches and meta-analyses. 58 A review of traditional medicine research in Sri Lanka: 2015–2019 4 Research gaps and challenges – The way forward for TM research in Sri Lanka 4.1 Introduction This section will focus on the challenges to developing the traditional medicine industry and research in Sri Lanka, covering: (1) Safety and standardization of herbal products (2) Supporting research: (i) clinical trials (ii) case reports (iii) community (iv) supportive TM research policies. (3) Developing the TM market: (i) public-private enterprise partnerships. (4) Protecting traditional medicine knowledge in Sri Lanka: (i) Intellectual Property Rights Act (ii) Draft Legal Framework for the Protection of Traditional Knowledge. (5) Summary of the current status and challenges of TM research. 4.2 Safety and standardization of herbal products 4.2.1 Standardization of herbal products Consistent quality of herbs, containing well-defined constituents, is required to provide reliable therapeutic effects. Standardization requires adjusting a herbal drug preparation to meet the defined content of a constituent or group of substances with known therapeutic activity (200). The standardization process faces numerous challenges related to marker identification, active principle(s), lack of defined regulations, non-availability of universally acceptable technical standards for testing and implementation of quality control/safety standards (toxicological testing) (201). 59A review of traditional medicine research in Sri Lanka: 2015–2019 The acceptance of a principal herbal compound as a future drug candidate requires correct identification, authentication and concentration of active principle and defined quantities of active components in polyherbal formulations. Regulation and standardization to ascertain the consistent chemical profile and biological activity of a future drug candidate include (200): (1) quality assurance by determining adulterants, pesticides residue, aflatoxin content, bacterial/fungal growth and heavy metals contamination, etc.; (2) prevention of adverse reactions by evaluating pharmacodynamics, pharmacokinetics, dosage, stability, shelf-life and toxicity (acute/chronic) etc.; and (3) reproducibility by repetitive testing using different batches to control batch-to-batch variation and development of standard assay markers. The Sri Lankan herbal drug industry should aim to exceed parameters above the basic WHO- GMP standards. Good manufacturing practices (GMP) lead to a more comprehensive approach to quality and risk management of the entire manufacturing process. The levels of implementation and enforcement of GMP critically determine the quality of products and, overall, successful development of the TM industry. For example, regulation of herbal products in the People’s Republic of China was developed on the basis of WHO-GMP and EU-GMP and mirrored the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) (202). PIC/Sis an international, non-binding arrangement that aims to achieve constructive co-operation in the field of GMP. The mission PIC/S is to lead international development, implementation and maintenance in GMP standards and quality systems of inspectorates in the field of medicinal products (http://www.picscheme.org). This is to be achieved by developing and promoting harmonized GMP standards and guidance documents; training competent authorities in particular inspectorates; assessing (and reassessing) inspectorates; and facilitating the cooperation and networking for competent authorities and international organizations. According to the Ayurvedic Act (203), registered Ayurveda practitioners may manufacture or prepare extemporaneously any traditional herbal medication for clinical use. Registered Ayurvedic hospitals or manufacturing firms are also permitted, provided the formulation is in accordance with the pharmacopoeia specifications and new formulations. The process of registration and market authorization of traditional medicineis carried out by the Ayurveda Formulary Committee of the Department of Ayurveda (http://www.ayurveda.gov.lk/) and committee members are appointed by the Health Minister of the Ministry of Health, Nutrition and Indigenous Medicine, Sri Lanka. However, the registration process is mainly conducted as desk reviews. Currently, there is no system for pharmacovigilance in traditional medicines in Sri Lanka. The future of all the formulary processes may be best placed under a pharmacopeia commission with a research and development unit, similar to what exists in India. This may help to address certain legal provisions in the country which limit access to some commonly used ingredients of Ayurvedic drugs, such as cannabis and opium. BMARI is taking steps to establish a GMP-compliant drug manufacturing unit with modern machinery. This step is an essential part of TM research and development. However, this depends on financial support from the Sri Lankan government. 60 A review of traditional medicine research in Sri Lanka: 2015–2019 4.2.2 Safety of herbal medicine An overview of the issues around the assessment of the safety of herbal products is the first priority in herbal drug development and faces several challenges (Fig. 12). The toxic effects of a herbal preparation may be attributed to the inherent toxicity of plant constituents and ingredients, manufacturing malpractice and contamination (200), botanical drug interactions, etc. Evaluation of the toxic effects of plant constituents of herbal formulations requires detailed phytochemical and pharmacological studies. It is, however, safe to assume that, based on human experiences in various cultures, the use of toxic plant ingredients has already been largely eliminated and recent reports of toxicity could largely be due to misidentification and overdosing of certain constituents (204). Fig. 10. Issues pertaining to safety of herbal medicine Issues pertaining to safety of herbal medicine Plant's inherant toxicity and lack of basic experiments Lack of standardization and quality control of raw materials Lack of a standard pharmacopeia available No systematic pharmaco-vigilance system Constraints of clinical trials Lack of good manufacturing practices Potential contaminants of herbal medicines include microorganisms, microbial toxins, pesticides, fumigation agents, radioactivity and presence of toxic compounds of toxic metals (204). Some of these contaminants have been identified by the Committee for Proprietary Medicinal Products (CPMP) of the European Community (EC) for use in controlling the purity of herbal medications in the European Union (EU) (205). The CPMP guidelines highlight the need for effective control of starting materials and finished products and emphasize the importance of good manufacturing practice. Safety standards should thoroughly address and include product specifications when considering product registration in 61A review of traditional medicine research in Sri Lanka: 2015–2019 regulatory authorities. Mosihuzzaman and Choudhary (2008) note that a key challenge is to objectively assess conflicting toxicological, epidemiological and other data and verification of herbal materials used. This requires a standard audit process to identify potential contaminants in herbal products. In this review, we have not focused on preclinical research data, but using standard process of preclinical studies prior to undertaking clinical research is of utmost importance. 4.3 Supporting TM research: Clinical trials, case reports, community-based studies and policies 4.3.1 Clinical trials When undertaking a clinical trial of a conventional drug, there are four issues that need to be addressed: (1) chemical-manufacturing-control (CMC) issues (2) non-clinical issues (3) clinical issues (4) ethical issues (206). Studies of herbal products face additional complexities, compared to conventional medicine research. These include the multi-ingredient composition of an intervention and the fact that typically substantial prior human use precedes its formal investigation. These features have important ramifications for CMC, non-clinical, clinical and ethical issues. International organizations and national authorities have published statements for supporting clinical trials of herbal products, whereby the justification required for conventional drugs has been adapted to traditional medicines. The International Conference on Harmonization (ICH) outlines the key information recommended for inclusion in a core clinical report of any study where therapeutic, prophylactic or diagnostic agent has been introduced in human subjects. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the United States of America to discuss scientific and technical aspects of drug registration. ICH’s mission is to achieve greater harmonization to ensure that safe, effective and high-quality medicines are developed and registered in the most resource-efficient manner. But it is still difficult to apply these guidelines to TM research. TM clinical trials may need a different approach or process to meet the ICH recommendations, particularly considering the fact that many of the products have been in use for long periods. In Sri Lanka, very few clinical trials have been conducted in herbal medicine development. Several clinical trials of herbal medicine in Sri Lanka did not undergo an institutional ethics review process but were registered on SLCTR. Clinical trials of herbal interventions should be conducted by graduate, qualified traditional (Ayurveda, Unani or Siddha) practitioners and allopathic practitioners. Clinical trials require institutional ethical clearance, for example, through the Ethics Review Committee of the Institute of Indigenous Medicine of the University of Colombo before commencement and should adhere to the latest version of the Declaration of Helsinki with regard to good clinical 62 A review of traditional medicine research in Sri Lanka: 2015–2019 practice (GCP). Investigators should achieve GCP training and certification before conducting a trial. Usually, these trials are conducted in educational institutes as a part of their postgraduate research or by manufacturing companies to find out the therapeutic efficacy and safety of herbal mixtures. Sometimes trials were conducted as comparative studies with Western medicine as positive control groups. For example, a formulation containing Salaciareticulate (Kothalahimbutu) has been tested in a clinical trial and found to be useful in type 2 diabetes as an adjunct to glibenclamide and metformin in standard dosage (207). Some of these clinically tested new formulas have not yet been included in the government-accepted Sri Lankan Ayurveda Pharmacopeia (208). To improve the safety and consistency of novel phytochemical preparations, regulatory authorities should maintain an updated version of pharmacopeia with product monographs. However, in Sri Lanka, this is not being followed due to the lack of a pharmacopeia commission. There is limited capacity for clinical research in traditional medicine in Sri Lanka due to limitations in human resources to undertake such studies and restricted institutional capacity. Some private companies are conducting clinical trials in Sri Lanka in collaboration with universities to research efficacy and support the medicinal claims of their products. The results of these clinical trials are published in indexed journals and this has enabled these companies to increase the market share of their products locally and overseas. Most clinical trials have been published in journals with limited impact For example, the Journal of Ayurveda Holistic Medicine is not ranked in SCImago and is not indexed on PubMED. Three journals, publishing specifically on Ayurveda, listed in PubMed, are Journal of Ayurveda and Integrative Medicine (Q2 complementary and alternative medicine), International Journal of Research in Ayurveda and Pharmacy (Q3 complementary and alternative medicine) and International Journal of Ayurveda Research (not assigned a quartile yet). To improve clinical trial publication potential, following a template such as the example provided in Appendix 2 may be helpful. 4.3.2 Case reports in traditional medicine Ayurveda/TM therapy is generally tailored to meet the unique presentation or patterns of symptoms and individual characteristics. This is not dissimilar to “omics”-based pharmacology, which aims to individualize or personalize by examining specific indications for therapies by identifying biomarkers in population. Case studies in TM are important due to completeness of the application of classical approach of Ayurveda/TM concepts such as prakriti, agni, dhatu, srotas, rasayana, shatkriyakala, agnibala, ojabala, manobala, etc. Among clinical research conducted during 2015–2019, 77% were case- based studies. And most of these case studies considered the basic TM concepts mentioned above in diagnosis and treatment. About 11% of the case studies directly exhibit the treatment regimens or formulations used exclusively in Sri Lankan indigenous medicine and Ayurveda during the review period. However, most of the regimens have incorporated indigenous formulas unique to Sri Lanka. Most of these case studies deal with “Kadum-bindum”, a speciality in Sri Lankan indigenous medicine that deals with fractures (orthopaedics). There have been favourable outcomes in almost all 63A review of traditional medicine research in Sri Lanka: 2015–2019 such case studies considered. It was evident in these case studies that the pastes and special oils used in Sri Lankan indigenous medicine has greatly improved fracture healing, in a shorter period of time. In some of the case studies, attempts have been made to manage complicated systemic illnesses like cancer (arbudha), HIV/AIDS and chronic kidney disease with favourable clinical outcomes. The therapies have greatly improved the quality of life of patients, according to these case studies. Many of the patients, who have sought indigenous treatments, have not only successfully addressed their main complaints, but have also considerably reduced other complications and associated diseases, such as dyslipidaemia, diabetes mellitus, hypertension, etc. Mandama, a childhood disease characterized by nutritional deficiency due to impaired digestion, has been considered in a few case studies. Some of these case studies were based on treatment regimens written in palm leaves on Sri Lankan indigenous medicine on Mandam-roga. Case studies relating to diseases of the skin, i.e. psoriasis, acne, etc., show that many patients seek Sri Lankan indigenous treatments when they have skin conditions. Some case studies state that patients seek allopathic treatments initially, which reduce symptoms, but they recur once medication is stopped. Therefore, they turn towards Sri Lankan indigenous medicine as it uses cleansing (blood purifying) methods, which, in some cases, completely resolve the problems. Findings from case studies require validation in large scale randomised controlled trials to translate these traditional medicines into practice. Some case studies had exemplified the importance of holistic and integrative approach involving body, mind and spirit. But only a few case studies (9%) were published in international peer-reviewed journals Therefore, there is a need to encourage researchers to publish their work in peer-reviewed journals. This low rate of peer-reviewed journal publication could be because of failure to adhere to scientific research methodologies or to provide accepted case study formats. It is also possible that there may not be any encouragement from the relevant authorities providing facilities for publication process. Another reason is that peer review journals that accept TM-based researches are sparsely available. To improve case report writing and publication potential, meeting the checklist requirements from the CARE guidelines provided in Appendix 3 may be helpful. A range of resources for writing case reports (case studies and case series) is available on https://www.care-statement.org/downloads. 4.3.3 Community-based participatory research in TM Community-based research can make important contributions to understanding how local environments impact the health status of a population. Community-based participatory research (CBPR) is a widely accepted collaborative approach to research that works to understand and protect public health by involving all partners in the research process (209). CBPR has emerged in the last decades to bridge the gap between science and practice through community engagement and social action to increase health equity (210). Relatively fewer community-based research have been conducted. 64 A review of traditional medicine research in Sri Lanka: 2015–2019 Some of the public health care services-based studies had adhered to KAP studies and survey models. There were no cohort and proper case-control studies found during this review period related to TM. There were around 9.7% studies, including KAP studies and survey-based studies, conducted on dengue fever. About 2% KAP studies was conducted on breast cancer among women. About 12% studies were conducted on diabetes, including QOL of patients and TM practices, prevalence studies, diabetic retinopathy screening programme and stress and diabetes-based screening. Around 17% nutritional status assessment survey studies were conducted during this review period while 2% were focused on prevalence of respiratory disorders among children. Also, 2% research has been conducted on the application of international human rights standards as a mechanism to protect the rights of people living with HIV/AIDS as a Sri Lankan perspective. Around 5% prevalence studies were conducted on musculoskeletal disorders, including osteoarthritis. Furthermore, 5% noncommunicable disease-based survey studies were conducted during this period. But there were no community- and TM-based, major studies found on chronic kidney diseases during this review period even though it is a significant health burden in Sri Lanka. Major drawbacks of most of these community-based health research and surveys included non-adherence to proper standard intervention design and implementation process Also, sample selection methods, measures and instrument design were not discussed properly and data collection, data analysis and interpretation were not properly mentioned. Therefore, it is important to provide proper guidelines and training to those who are involved in community-based TM research in Sri Lanka. We would suggest the following important studies to be conducted as CBPR in Sri Lanka: to study community’s access to TM care and health problems commonly addressed in TM care setting – this can help set the stage for real policy change on a local level; to study the rise in NCD and available measures in TM for prevention; and to study the context of improving maternal and child health through TM. As a solution to the poor quality of reporting of medical research, guidelines for different types of study designs have been developed in conventional medical systems, which secure accurate reporting and transparency for reviewers and readers of the scientific community. It is of utmost importance to implement these guidelines to maintain the quality of reporting TM-based medical research. 4.3.4 Supportive policies and funding for TM research There are several incentives provided by the government to promote research and development of new innovations. These are in the form of individual incentives like consideration for promotions and special allowances, and fiscal incentives to institutions and priority consideration in research grant schemes. Individual R&D contributions are considered for promotions to the next level at research institutions and universities. Published research, patents and the ability to attract research grants from outside sources are allocated marks in promotion schemes. Institutions provide limited opportunities for local and foreign 65A review of traditional medicine research in Sri Lanka: 2015–2019 training, scholarships, foreign leave and sabbatical leave to enhance knowledge and assist career advancement. Research scientists are eligible for research allowance as a part of their salary. The National Science and Technology Commission (NASTEC) policy encourages all researchers, including health-related researchers, to collaborate with business partners at the outset of a research project. The two funding bodies functioning under the Ministry of Science, Technology and Research, National Science Foundation and National Research Council (NRC), also consider alliance with business partners as a criterion in funding research proposals in certain grant schemes. The Support Scheme for Supervision of Research Degrees (SUSRED) is an award given by the National Science Foundation to supervisors with postgraduate research degrees (MPhils and PhDs) and institutions that support postgraduate research in Sri Lanka, in recognition of the service to the nation. This scheme was implemented in 2011 to motivate, support and recognize scientists in all areas of science and technology. The Overseas Special Training Programme (OSTP) financially assists scientific and technical personnel (science administrators, science educators, S&T policy-makers and science communicators) as well as full-time research students to receive overseas training for up to 12 months. The International Partnerships for Science and Technology (IPSAT) programme helps Sri Lankan scientists, engineers, science and technology policy-makers and research personnel to undertake collaborative R&D/S&T service assignments with foreign-based scientists for stipulated periods in Sri Lanka. The President’s Awards for Scientific Publications was started in 2001 by the NRC to recognize scientists whose work attained international standards. Under this scheme, Sri Lankan scientists, based in the country, who publish papers in Science Citation Index (SCI)-indexed journals, receive certificates of appreciation. The criteria for making this award were made more stringent recently by restricting the award to those who publish in SCI journals with an impact factor of one or more. The NASTEC initiated an award system in 2006 to encourage young scientists and recognize their achievements. These awards are presented under two categories, namely scientific research and popularization and promotion of science. The awards are open to members of the Young Scientists Forum (YSF). The Sri Lankan Budget 2012 announced a range of tax incentives, including reduction of tax on research income, reduction in personal income tax of all those engaged in research and technology, and reduction in income tax for all institutions engaged in research and technology. Such institutions were also exempt from value added tax (VAT). The budget further proposed a triple tax deduction in relation to research and development expenditure undertaken by private enterprises through government institutions, to encourage private institutions to use government research facilities. Under this scheme, a private company is entitled to a tax deduction of three Lankan rupees for every single Lankan rupee invested in R&D in the government sector. Currently, there are few north-south or south-south partnerships for capacity-building in the area of health innovation established in Sri Lanka. This is mainly due to restricted capacity in the industrial sector for original research and new product development. Most industries focus on replicating technologies and products that are already available. The National Science Foundation, however, has two funding schemes that aim to facilitate such collaborations. BMARI has established needs-based priorities for health R&D, such as research on cancer, diabetes, CKD, cardiovascular diseases and dengue. These research areas have been prioritized 66 A review of traditional medicine research in Sri Lanka: 2015–2019 in keeping with the National Health Research Policy. Although limited R&D work has been carried out in the past, BMARI is planning to improve the capacity to work on medicines development and production. Apart from the government facility to manufacture Ayurvedic medicines, many private- sector industries are involved in R&D for manufacturing medicines. 4.4 Developing the TM market 4.4.1 Public-private enterprise partnerships Investment in pharmaceutical research and development has increased substantially in the past few years with multidisciplinary research approaches in Sri Lanka on a par with global investment in herbal pharmaceutical research and development (R&D). But, similar to the global scenario, this has not translated into a corresponding increase in output in terms of new drugs approved. This indicates that therapeutic innovation has become more challenging (211). At the same time, health-care costs are steadily spiralling, fuelled by the ageing of the population and a parallel rise in the chronic disease burden (211,212). According to research findings of Vaudano (Vaudano, 2013), many pharmaceutical companies are realizing that a paradigm shift in the industry’s R&D strategy is the only way of reversing the ongoing negative trend (211). Novel strategies, based on an integrated and collaborative approach, are required, building on innovation and leveraging on the strengths and input of all stakeholders in the health system, with the shared goal of delivering effective and sustainable health-care solutions to the society (213). In 2004, the US Food and Drug Administration (FDA) acknowledged a growing gap between the rate of basic science discovery and the translation of these discoveries into development of medical products. To address this gap, the FDA instituted the Critical Path Initiative (CPI) (206), which called for increased efforts to catalyse innovation in product development through the launch of several initiatives. The CPI further emphasized that a joint effort between the research community, industry, and FDA scientists was essential to realize the CPI vision (214). To this end, the FDA convened both external stakeholders and FDA scientists to identify research priorities that could guide the FDA to bring focus to specific unmet public health needs. This effort resulted in the Critical Path Opportunities List (CPOL) published in 2006. The stakeholders identified six top priority focus areas related to the safety, efficacy, quality and performance of FDA-regulated products (17): priority area 1: Better evaluation tools; priority area 2: Streamlining clinical trials; priority area 3: Harnessing bioinformatics; priority area 4: Moving manufacturing into the 21st century; priority area 5: Developing products to address urgent public health needs; and priority area 6: At risk populations–paediatrics. 67A review of traditional medicine research in Sri Lanka: 2015–2019 In the Sri Lankan context, it may be possible to adapt the CPI developed by the US government. This may increase efforts to catalyse innovation in product development through public-private partnership. Within this CPI, traditional medicine and knowledge can be upgraded to harness opportunities for new clinical drug developments or standardize current herbal products to achieve global acceptability. This lead will reduce health-care expenditure for drug import to the country in the future. For the industry to partner with TM research institutions in the development of new TM medicines, financial incentives are needed. Investment by the industry is not viable if there is no way to protect or patent or retain market exclusivity or guard research and data. In Australia, a regulatory reform is underway to improve the competitiveness and provide incentive. The new Data Protection Scheme for Assessed Listed Medicines aims to incentivize innovation by protecting the results of investment in the development of TM products (known as complementary medicines in Australia) (215). The scheme is designed to prevent competitors from seeking market authorization of generic forms of an assessed listed medicine. Competitors will not be able to utilize data that was generated and used by the sponsor of the original TM medicine to obtain market authorization. This provides industry with the means to finance further research and development activities by preventing others from capitalizing on their investment and innovation. Clinical trial information supporting a new intermediate clinical indication will be restricted to a five-year protection period for use only by the owner of the clinical trial data. 4.5 Protecting traditional medicine knowledge in Sri Lanka 4.5.1 Intellectual property rights Intellectual property rights (IPR) issues are not yet addressed in medicinal products. According to our findings (Perera and Shridhar, 2017), Sri Lanka was unable to build an effective intellectual property rights regime yet, especially for the traditional medical sector. Therefore, the Sri Lankan traditional medicine sector has to face several difficulties, especially in international trade, losing many opportunities to use its own traditional medical knowledge for the benefit of future generations due to the inability to patent traditional knowledge. Sri Lanka has implemented some rules and regulations in this regard to protect plant varieties and traditional knowledge. Most of these Acts and ordinances deal with natural resources, which collectively indicate a policy in favour of physical protection of natural resources, but are not specific laws relating to medicinal plants and traditional knowledge. Therefore, it is important to develop guidelines and laws and enforce them to ensure benefits of sharing with the community for commercial use of traditional knowledge. The implementation of the proposed Bill on “The protection of traditional knowledge in Sri Lanka”, drafted and placed in the world intellectual property indicators of WIPO (World Intellectual Property Organization) in 2009 with several amendments, would address many of these issues. The National Intellectual Property Office (NIPO) is in charge of implementing IPR-related activities in the country. Still, Sri Lanka does not have any legislation comparable to the Bayh–Dole Act or the Patent and Trademark Law Amendments in the USA. The Intellectual Property Rights Act No: 36 of 2003 has replaced the code of Intellectual Property Act No: 52 of 1979. 68 A review of traditional medicine research in Sri Lanka: 2015–2019 This Act has introduced several types of property rights, including copyrights, related rights, expression of folklore, industrial designs, marks, patents, unfair competition, undisclosed information, geographical indication, etc. According to the Act: “…plants, animals and other micro-organism other than transgenic micro-organism and an essentially biological process for the production of plants and animals other than non-biological and Microbiological processes shall not be patentable (Section 62.1).” However, an invention can be patentable if it is new, involves an inventive step and is industrially applicable. Thus, identifying new plant varieties can be regarded as a new innovation and can be patentable. Furthermore, with regard to traditional knowledge, the Act addresses expression of folklore. Section 24 of the Act offers a sui generis form of protection to the expression of Sri Lanka’s folklore. Section 5 of the Act says that “expression of folklore can be identified as a group oriented and tradition based creation of groups or individuals reflecting the expectations of the community as an adequate expression of its cultural and social identity, its standards and values as transmitted orally by imitation or by other means”. 4.5.2 Draft Legal Framework for the Protection of Traditional Knowledge (2009) A Legal Framework for the Protection of Traditional Knowledge in Sri Lanka was prepared in 2009 to provide protection and proper management of traditional knowledge in the country. However, this draft has not yet been approved. According to the draft document: “The Government of Sri Lanka recognizes: the importance and value of traditional knowledge in all the fields of human endeavor including scientific, technological, industrial, economic, cultural, educational, social and spiritual; and the necessity to promote the protection, development, conservation and preservation of traditional knowledge; meet the legitimate needs and expectations of the holders of traditional knowledge; secure the respect and recognition for the traditional knowledge and the holders thereof for their contribution to the knowledge and development; ensure fair and reasonable benefits to the holders of traditional knowledge for the use of traditional knowledge outside the traditional context; regulate use, disclosure, acquisition, preservation and conservation, management, development and application of traditional knowledge; discourage, control, counter and stop misuse of, misappropriation of an unauthorized access to, traditional knowledge; and enable the human race to duly benefit from the traditional knowledge of Sri Lanka.” (216) “Traditional knowledge” in the Act refers to the content or substance of knowledge that is the result of intellectual activity and insight in a traditional context and includes the knowhow, skills, innovations, practices and learning that form part of traditional knowledge systems. It also refers to knowledge that is embodied in the traditional lifestyle of a community or people or is contained in written or codified knowledge systems passed down to generations. Also, as per the ACT, “traditional knowledge” is not limited to any specific technical field and may include agricultural, environmental, health care and medicinal knowledge, associated with genetic resources or other components. The “holder of traditional knowledge” is defined as an individual or group of individuals or a community in Sri Lanka who or that is in possession of traditional knowledge distinctively linked to 69A review of traditional medicine research in Sri Lanka: 2015–2019 such an individual, a group of individuals or a community, and that is not in the public domain, but does not include a person or a group of persons incorporated or not incorporated who have acquired such traditional knowledge in violation of the provisions of this Act. The draft Act calls on the Government of Sri Lanka representing the people of Sri Lanka to preserve, develop and manage traditional knowledge in the public domain for the benefit of the people of Sri Lanka and future generations and to encourage and promote scientific research and innovations, involving and relating to such traditional knowledge. The Director General of Intellectual Property will be responsible for discharging this duty on behalf of the Government of Sri Lanka with the cooperation of the government agencies dealing with related subjects such as indigenous medicine, agriculture, bio-diversity, environment, fauna and flora, wildlife and forest, whenever he/she needs such cooperation and in the manner and circumstances in which he/she needs such cooperation. Section 6 of the draft document explains that traditional knowledge will be protected using several strategies such as: access to traditional knowledge; misappropriation of traditional knowledge; acquisition of traditional knowledge by theft, bribery, coercion, fraud, trespass, breach of contract or inducement of breach of contract, breach of confidence or confidentiality or inducement of breach of confidence or confidentiality, breach of fiduciary obligations or other relations of trust, deception, misrepresentation, the provision of misleading information when obtaining prior informed consent for access to traditional knowledge; unauthorized disclosure or use of traditional knowledge by any person or group of persons, corporate or unincorporated, who legitimately had access to traditional knowledge; use of traditional knowledge that violates the terms that were mutually agreed on as a condition of prior informed consent concerning access to that knowledge; false claims or assertions of ownership or control over traditional knowledge, including acquiring, claiming or asserting intellectual property rights over traditional knowledge- related subject matter, when those intellectual property rights are not validly held in the light of that traditional knowledge and any conditions relating to its access; and willful offensive use of traditional knowledge of particular moral or spiritual value to its holders by third parties outside the customary context, when such use clearly constitutes a mutilation, distortion or derogatory modification of that knowledge or is contrary to public order or morality. Section 9 (1) of the proposed Act states that there shall be a register for traditional knowledge maintained and kept by the Director General of Intellectual Property. The objectives of the register will be to: collect and preserve the traditional knowledge; encourage and promote the use of traditional knowledge; 70 A review of traditional medicine research in Sri Lanka: 2015–2019 prevent unlawful access to and patenting of traditional knowledge; and ensure the equitable sharing of benefits arising from access to such traditional knowledge. The Director General of Intellectual Property shall establish and maintain a database containing traditional knowledge in the public domain. Furthermore, Article 15 (2) of the Act states, “The Commissioner for Ayurveda and other concerned government agencies shall identify, collect and transmit such knowledge to the Director General of Intellectual Property to be included in the database.” The Director General of Intellectual Property may also create digital libraries and other records of traditional knowledge as may be prescribed by the minister. In conclusion, conventional IPR discourage the disclosure of traditional knowledge and hamper the documentation of traditional knowledge. Thus, there is a need to develop an alternative, sui generis system, which will meet the needs of holders of traditional knowledge. Such a system will not only ensure the sharing of benefits, but will also create an environment which would encourage the disclosure of traditional knowledge that would otherwise be lost to the world. The development of such a sui generis system is, however, no easy task and requires concerted effort of the local community. Traditional knowledge, which is in the public domain, needs to be documented in the form of traditional knowledge digital libraries as suggested in the proposed Act of 2009. Documenting traditional knowledge includes recording it, writing it down, taking pictures of it or filming it – anything that preserves it in an accessible form. It is different from the traditional ways of preserving and passing on knowledge within a community and can promote or damage a community’s interests, depending on how the documentation is carried out. It is important to develop guidelines or laws and enforce them to ensure benefit-sharing with the community for commercial use of traditional knowledge. And the traditional knowledge should be recognized in the form and concepts of the traditional medicine system. Creating a system for the registration of innovations by inventors would be equivalent to giving inventors the right to challenge any use of their innovations without prior permission. For useful innovations, some kind of petty, patent-giving protection for a limited duration might be appropriate, as per the Australian example. In light of intellectual property issues, it is absolutely important to implement the proposed Act, “The protection of traditional knowledge in Sri Lanka”, which was drafted and placed at WIPO in 2009 with further amendments by stakeholders responsible with regard to TM in Sri Lanka. 4.6 Summary of current status and challenges of TM research and development When considering the framework for TM research in Sri Lanka (Chapter 2), the findings of the scoping review (Chapter 3) and the challenges discussed in this chapter, and the strengths, weaknesses, opportunities and threats (SWOT) to TM research in the country can be summarized as follows: 71A review of traditional medicine research in Sri Lanka: 2015–2019 Fig. 11. SWOT analysis of TM-based clinical research process in Sri Lanka Strengths • Government- accepted TM systems and separate section in the Ministry • Strong support research system, with educational institutions affiliated to universities with teaching hospitals, 49 Ayurveda hospitals and 159 Ayurveda central dispensaries • A separate research institute for TM/Ayurveda (BMARI) • Well-developed ethics review process having local and international affiliations • Trained postgraduate researchers Weaknesses • Limited funding capacity for clinical research • Low scale of operations and technology in research, including laboratory facilities • No well-equipped research-based hospital/s available for clinical trials • Lack of collaboration with mainstream conventional medicine systems • Low level of private sector involvement in TM research • No clear mechanism to conduct trials if private sector is interested and has initiated • Low rates of publications in SCImago-indexed journals Opportunities • Natural, traditional and safe approaches are being welcomed internationally • Increased scope for innovation and change in approach to therapies • Estimated global market size is increasing for TM- based products • Exports of herbal products, backed by clinical trials, are highly accepted across the globe Threats • Sector might become irrelevant to issues of health care due to lack of innovation/R&D • Brand recognition of alternative medicinal systems, such as Chinese, Latin and South American, African, etc., rising • Intellectual property rights issues • Criticism for herb- mineral drugs safety • Underdeveloped pharmacovigilance system The challenges specifically for herbal products development include: (1) There is a lack of quality assurance and control in manufacturing of herbal/TM products, which is a confounding factor in achieving global trade. (2) The informal sector manufacturing and selling herbal drugs and related products on a small scale is large, and this often makes it impossible to identify quality products. (3) Many counterfeit product developers are involved in the trade. (4) Information related to herbal products and their usage is scattered and not available in electronic form, thereby making it difficult to access. 72 A review of traditional medicine research in Sri Lanka: 2015–2019 (5) There are few multicentred clinical research projects for herbal formulations. (6) Communication between policy-makers of orthodox Western medicine and those of Ayurvedic medicine is not adequate (i.e. lack of collaboration between the Ayurveda Formulary Committee and the Cosmetic and Drug Devices Authority). (7) There is a lack of trained resource persons in herbal product regulation bodies. (8) Ayurvedic pharmaceutical industry is not motivated to focus on pharmacovigilance of herbal/TM products. Hence, there is a lack of post-market surveys about drug safety. (9) There is a need to develop standard pharmacopeia for herbal drugs/TM. (10) There is no legal classification of herbal drugs/TM, according to their therapeutic usage and rules and regulations are not enough to bind patients to prescriptions. Therefore, the consequences of over-the-counter drugs could be serious. (11) There is no proper recall system for pharmaceutical preparations in Sri Lanka. These issues and challenges may be relevant to other countries dealing with herbal-related product development and marketing. According to the WHO Traditional Medicine Strategy 2014–2023 (WHO, 2013), Member States need to adhere to the following strategic actions in the context of sustainable development of herbal medicine sector. (1) Based on the greatest potential risks and/or benefits attributable to T&CM used in their country: a. monitor the safety of T&CM; b. identify sources of evidence, whether historical, traditional or scientific, which support or invalidate a particular therapy; and c. determine the risk/benefit profile, including cost-effectiveness. (2) Promote research and development, innovation and knowledge management. (3) Encourage knowledge generation, translation and dissemination by establishing a comprehensive and inclusive approach to T&CM research and development, including quality and cost-effectiveness. (4) Develop a national research agenda, which acknowledges and includes various types of research models where appropriate. (5) Develop and share appropriate methods and criteria for evaluating the safety, efficacy and quality of T&CM products and for assessing the value of T&CM practice (e.g. develop resources for research, devise appropriate research methodologies and encourage investment). (6) Prevent misappropriation of T&CM by implementing the relevant international instruments in line with the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, adopting or amending national intellectual property legislation and enacting other defensive protection strategies. (7) Protect and conserve T&CM resources, particularly knowledge and natural resources. 73A review of traditional medicine research in Sri Lanka: 2015–2019 (8) Identify how T&CM information is communicated through practitioners, product advertising, practices and media. (9) Foster dialogue and partnership between stakeholders. Where relevant to the national need, seek input from international partners with additional information, especially concerning global trends and lessons learned. (10) Publish standard treatment guidelines for use of T&CM as well as a list of essential herbal medicines, based on research evidences. Sri Lanka has still not effectively taken the strategic actions mentioned above to upgrade the country’s traditional medicine systems. But Sri Lanka is modestly adapting a positive research policy development process, adhering to considerable standard to implement ethical health research strategy, to traditional medicine systems. According to the review, Sri Lanka has adhered and contributed to the following chief aspects to upgrade TM research in order to improve the health status and the health economy of the nation. It has implemented the Code of Conduct for Health Research in Sri Lanka (CCHRS). It has adhered to the standard ethics review process in health research, following updated versions of ethics principles and ERCs affiliated to world ethics governing bodies. The Sri Lanka Clinical Trials Registry is a primary registry linked to the WHO Registry Network of the International Clinical Trials Registry Platform (WHO-ICTRP). The Sri Lanka Medical Association has taken the initiative to establish SLCTR, which will provide a facility for registration of trials conducted in Sri Lanka or overseas and help promote collaborative research between Sri Lankan and foreign researchers. There are a number of government institutions in Sri Lanka actively involved in traditional systems of medicine research and development and policy-making and providing grants. There are a few incentives provided by the government to promote research and development targeting new innovations in TM. 74 A review of traditional medicine research in Sri Lanka: 2015–2019 References 1. Qi Z. 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Rumaiza, editor Pessary treatment for uterine prolapse and health-related quality of life: a case study. ICAUST; 2016. 149. BMARI. Wound healing effect of traditional herbal formulation (Pachchennai oil) on Varicose ulcer. In: Institute BMAR, editor. Sri Lanka2017. 150. Kumaradharmasena L, editor An Ayurvedic approach of computer vision syndrome and management with Tripalaghrit Akshitharpana: A case study. ICAUST; 2018. 151. Surangi K, editor Ayurvedic management of Macular odema (3rd patalagathatimira): A case study. . ICAUST; 2018. 152. BMARI. A case study on management of chronic wound with polyherbal formulation. In: Institute BMAR, editor. 2017. 153. Sing L, editor). Effect of Ayurvedic therapies in the management of infected wounds. ICAUST; 2017. 154. Ralapanawa DMPUK, Jayawickreme KP, Ekanayake EMM, Kumarasiri PVR. A study on the knowledge and attitudes on advanced life support among medical students and medical officers in a tertiary care hospital in Sri Lanka. 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ICAUST; 2017; Sri Lanka. 171. Silva, Thathparan, editors. Analytical survey of patients attending to swithra (vitiligo) clinic. . ICAUST; 2017; Sri Lanka. 172. Lakmali, editor A Study of the factors influencing for the patterns of consumer behavior in the medical sector. ICAUST; 2015; Sri Lanka. 173. Fonseka, editor Role of Diabetic Retinopathy Screening. ICAUST; 2015; Sri Lanka. 174. Jayalal, editor Study on the Need of Stress Management in Ayurveda Health Care System in Sri Lanka. ICAUST; 2015; Sri Lanka. 175. Loganathan, editor A study of distribution of “Diagnosed hypertension” in Mathagal J/151 Grama Niladhari division during from April to June 2012. I. ICAUST; 2015; Sri Lanka. 176. Zabir, editor Knowledge, Attitude and Preventive Measures of Breast Cancer among Maligawatta Area Women. ICAUST; 2015; Sri Lanka. 177. Sandamali, editor Prevention of suicide (with especial reference to “sumithrayo” in panduwasnuwara western d.s. in kurunegala district). ICAUST; 2015; Sri Lanka. 178. Munasinghe, editor Effect of obesity on quality of certain semen parameters of Sri Lankan males. ICAUST; 2015; Sri Lanka. 179. Rathnakara, editor Prevalence of respiratory disorders of children, attending the Ayurveda Teaching Hospital, Colombo. ICAUST; 2015; Sri Lanka. 180. Wickramasinghe A, editor Comprehensive survey of patients attending to the orthopedic clinic in Ayurveda teaching hospital, Borella. ICAUST; 2015; Sri Lanka. 181. Kumari, editor An assessment of the perception of stress in type 2 diabetic patients in accordance with perceived stress scale (PSS 10). ICAUST; 2015; Sri Lanka. 81A review of traditional medicine research in Sri Lanka: 2015–2019 182. 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Strengthening the Reporting of OBservational studies in Epidemiology (STROBE) [Available from: https://www.strobe- statement.org/index.php?id=strobe-home. 83A review of traditional medicine research in Sri Lanka: 2015–2019 Annex 1 Reporting observational studies – STROBE statement (217) Item No Recommendation Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract (b) Provide in the abstract an informative and balanced summary of what was done and what was found Introduction Background/ rationale 2 Explain the scientific background and rationale for the investigation being reported Objectives 3 State specific objectives, including any pre-specified hypotheses Methods Study design 4 Present key elements of study design early in the paper Setting 5 Describe the setting, locations and relevant dates, including periods of recruitment, exposure, follow-up and data collection Participants 6 (a) Cohort study — Give the eligibility criteria and the sources and methods of selection of participants. Describe methods of follow-up Case-control study — Give the eligibility criteria and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls Cross-sectional study — Give the eligibility criteria and the sources and methods of selection of participants (b) Cohort study — For matched studies, give matching criteria and number of exposed and unexposed Case-control study — For matched studies, give matching criteria and the number of controls per case Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders and effect modifiers. Give diagnostic criteria, if applicable Data sources/ measurement 8* For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group Bias 9 Describe any efforts to address potential sources of bias Study size 10 Explain how the study size was arrived at 84 A review of traditional medicine research in Sri Lanka: 2015–2019 Quantitative variables 11 Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why Statistical methods 12 (a) Describe all statistical methods, including those used to control for confounding (b) Describe any methods used to examine subgroups and interactions (c) Explain how missing data were addressed (d) Cohort study — If applicable, explain how loss to follow-up was addressed Case-control study — If applicable, explain how matching of cases and controls was addressed Cross-sectional study — If applicable, describe analytical methods taking account of sampling strategy (e) Describe any sensitivity analyses Results Participants 13* (a) Report numbers of individuals at each stage of study — e.g. numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up and analysed (b) Give reasons for non-participation at each stage (c) Consider use of a flow diagram Descriptive data 14* (a) Give characteristics of study participants (e.g. demographic, clinical, social) and information on exposures and potential confounders (b) Indicate number of participants with missing data for each variable of interest (c) Cohort study — Summarize follow-up time (e.g. average and total amount) Outcome data 15* Cohort study — Report numbers of outcome events or summary measures over time Case-control study — Report numbers in each exposure category or summary measures of exposure Cross-sectional study — Report numbers of outcome events or summary measures Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (e.g. 95% confidence interval). Make clear which confounders were adjusted for and why they were included (b) Report category boundaries when continuous variables were categorized (c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period Other analyses 17 Report other analyses done — e.g. analyses of subgroups and interactions, and sensitivity analyses 85A review of traditional medicine research in Sri Lanka: 2015–2019 Discussion Key results 18 Summarize key results with reference to study objectives Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence Generalizability 21 Discuss the generalizability (external validity) of the study results Other information Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based 86 A review of traditional medicine research in Sri Lanka: 2015–2019 Annex 2 Template for writing a clinical trial research report Template for clinical research article (www.springer.com) Manuscript preparation: Authors of randomized clinical trials must adhere to the CONSORT guidelines; authors of descriptive or observational studies must adhere to STROBE guidelines; and complete the STROBE checklist at the end of the template. Title page Title: Your title should contain no more than 80 characters including spaces. Running title: Provide a running title less than 40 characters including spaces. Provide highest academic degree for all the authors. Academic affiliations Conflict of interest statement: Any and all personal or institutional financial support related to the study must be noted here; see guidelines for format. — If any author has consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.; if so, please note. — If you or any author have received or may receive any personal payment or in-kind benefit or other professional benefits from a commercial entity (e.g. serve as a consultant), please note, “Each author () certifies that he or she has or may receive payments or benefits from a commercial entity () related to this work”, and note the initials of those authors who received funding in and the source in the parentheses. — If any author has directly received research funding and/or has potential conflicts of interest, state, “One or more of the authors () has received funding from” and note the source and the initials of those authors who received funding in the parentheses. — If the institution of the authors has received any sort of support related to the work, state, “The institution of the authors () has received funding from” and note the source and the initials of those authors who received funding in the parentheses. If no author has received any financial support please, note, “Each author certifies that he or she has no commercial associations (e.g. consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article.” Ethical Board Review statement: Institutional ethical board review is required for any study involving humans, human material or data or animals; a statement of approval must be noted here; see guidelines for format 87A review of traditional medicine research in Sri Lanka: 2015–2019 Work performed at [insert name of institution or institutions in the case of authors from multiple institutions] Word Count (Introduction through Discussion): Generally, limit manuscripts to fewer than 3000 words. Corresponding author: Provide complete contact information for corresponding author, including phone, FAX and e-mail address. Abstract Your abstract must be structured with the following five sections and contain fewer than 250 words. Background: Questions/purposes: Patients and methods: Results: Conclusions: Level of evidence: Below abstract provides a level of evidence and study description for your primary research question (see website for guidelines). The study descriptions include one of the four types as found in the guidelines. An example of the format is: “Level of evidence: Prognostic study, level II-1 (retrospective study). See the guidelines authors for a complete description of levels of evidence.” Introduction (maximum of 500 words) All manuscripts must contain an introduction, typically 3-4 paragraphs. Prepare text and introduction in a question/purpose format: First question or purpose must be designated as a primary research question for assigning a level of evidence. Generally, formulate no more than 2-4 questions or purposes; each should be sufficiently important that their answers would also appear in the abstract. One paragraph of background, one or two of rationale and a final paragraph only stating the questions or purposes of the study. Patients and methods Authors must provide all relevant material in the STROBE guidelines at the end of the template and complete the checklist. Generally, use the following order: Study design Relevant patient demographics Power analysis (if more than one cohort) Description of treatment or surgery Description of postoperative treatment 88 A review of traditional medicine research in Sri Lanka: 2015–2019 Description of follow-up routine Description of outcome measures Statistical analysis, if any; the description of a statistical analysis must reflect the questions and study design. Results (maximum of 500 words) Begin with any paragraphs needed to persuade the reader of the validity of your methods if using new or unvalidated methods or to report general findings of interest (e.g. complications) not related to a specifically posed questions. Then, in the subsequent paragraphs, ensure a one-to-one correspondence of questions raised in the Introduction and answers provided in Results. Next provide one paragraph for each explicit question. You may end with a paragraph or two of unanticipated results or a description of complications. Discussion (maximum of 1000 words) Begin with a restatement of background and rationale, then state your questions or purposes. Briefly explore each major study limitation. Then compare and/or contrast your results with observations or data from the literature. Write one paragraph of comparisons for each question or purpose. When comparing substantial amounts of data from the literature, provide a table or tables of comparative data noting outcome times, where relevant. End with a synthesis of your results and those in the literature rather than only conclusions from your own data. Acknowledgments: Note any non-financial acknowledgments. Begin with, “The authors wish to thank…” 89A review of traditional medicine research in Sri Lanka: 2015–2019 Annex 3 Template for writing a case report Member States of the WHO South-East Asia (SEA) Region have prioritized attention to research in traditional medicine and supported substantial research activity to promote evidence-based traditional medicine practices. Many research reports have been published in national and international journals. However, despite many such research studies in countries, these have not been analysed systematically in terms of topic, area of research, and issues, challenges and gaps. On account of this, research findings are inadequately reflected in policy guidance on the development of traditional medicine and its appropriate integration with the public health care delivery systems. This publication provides a detailed account of traditional medicine research status in Sri Lanka during 2014–2019 with reference to research activities, types of clinical research, main health conditions studied, and the gaps, issues and challenges relating to clinical research in traditional medicine. It also enumerates the existing principles and practices for conducting research, including code of conduct, ethics, monitoring and evaluation, regulatory systems, reporting and dissemination, legal frameworks for protecting intellectual property rights, and administrative procedures. A review of in Sri Lanka: 2015–2019 traditional medicine research 9 7 8 9 2 9 0 2 2 8 9 8 1 ISBN 978-92-9022-898-1
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A review of traditional medicine research in Sri Lanka: 2015–2019
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