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Approach to study the efficacy and safety of new complementary and alternative medicine formulations: Lesson during COVID-19 from Sri Lanka

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dc.contributor.author Pilapitiya, S.
dc.contributor.author Jayasinghe, S.
dc.contributor.author Silva, A.
dc.contributor.author Wickremasinghe, R.
dc.contributor.author Paranagama, P.
dc.contributor.author de Silva, J.
dc.contributor.author Lekamwasam, S.
dc.contributor.author Kularatne, S.A.M.
dc.contributor.author Wanigasuriya, K.
dc.contributor.author Kaluthota, S.
dc.contributor.author Sumathipala, S.
dc.contributor.author Rathnnasooriya, C.
dc.contributor.author Siribaddana, S.
dc.date.accessioned 2023-10-24T04:16:14Z
dc.date.available 2023-10-24T04:16:14Z
dc.date.issued 2023
dc.identifier.citation WHO South-East Asia Journal of Public Health.2023;12(1):57-62. en_US
dc.identifier.issn 2304-5272 (Electronic)
dc.identifier.issn 2224-3151 (Print)
dc.identifier.uri http://repository.kln.ac.lk/handle/123456789/26779
dc.description Indexed in MEDLINE. en_US
dc.description.abstract COVID-19 affected Sri Lanka from early 2020, a time of considerable ignorance accompanied by wide media coverage of a devastating epidemic in Italy and Europe. Many were attracted to complementary and alternative medicine (CAM) or traditional medicine (TM) in this desperate situation. Several preparations were claimed to be effective against COVID-19 globally. Dammika Bandara Syrup© was one such preparation promoted for preventing and treating SARS-CoV-2 infection. It was based on bees' honey, pericarp and mace of Myristica fragrans (nutmeg), the seed of Foeniculum vulgare and fresh rhizome of Zingiber officinale, all believed to have anti-viral properties. Following an unpublished clinical study claiming efficacy, Dammika Bandara Syrup© gained wide media publicity and political patronage. The producer claimed of Goddess Kali revealing the formula added an anthropological, cultural, and religious complexity to the issue. The demand for the product increased rapidly as a debate raged both in public and in the parliament on utilizing such products in combating COVID-19. The Department of Ayurveda, which is statutorily responsible for regulating CAM/TM had to respond to the situation. The legislation to regulate such indigenous medicinal products was weak, and the crisis deepened as thousands converged to the production facility, defying mobility restrictions introduced to control COVID-19. This led to the Ministry of Health requesting academics to form a team and conduct a clinical trial to prove its efficacy. This paper outlines the process and issues faced during the regulatory approval for the trial in a polarized political environment. Some health professionals accused the researchers of bowing to political pressure and questioned the scientific justification for the trial. However, the team considered this as an opportunity to streamline a path for research into CAM/TM therapies in situations such as COVID-19. Several processes were identified and addressed, such as the provisional registration of CAM preparations, assessing the potential efficacy of a CAM product, confirmation of authenticity and safety, standardization and supervision of production respecting cultural identities, obtaining approval for human use, choice of comparators, and ethical issues. We believe the study has helped set standards and a benchmark for CAM and TM research in Sri Lanka. en_US
dc.language.iso en en_US
dc.publisher Wolters Kluwer - Medknow en_US
dc.subject COVID-19 en_US
dc.subject Clinical en_US
dc.subject Sri Lanka en_US
dc.subject medicine en_US
dc.subject traditional en_US
dc.subject trial en_US
dc.title Approach to study the efficacy and safety of new complementary and alternative medicine formulations: Lesson during COVID-19 from Sri Lanka en_US
dc.type Article en_US


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