A critical analysis of CTRI registered AYUSH studies for COVID- 19

BACKGROUND: The COVID-19 pandemic has provided an opportune time to evaluate the efficacy of traditional medicine. Many clinical studies involving AYUSH systems are being initiated and registered with Clinical Trials Registry - India (CTRI) since last few months. OBJECTIVE: The present work is an analysis of different characteristics of these studies on the basis of available datasets. MATERIAL AND METHODS: COVID-19 related clinical studies involving the healthcare systems of AYUSH, registered on CTRI between 1(st) February 2020 and 24(th) August 2020, were searched. They were analysed as per different characteristics such as registration month, study sites, aim, sample size, population, setting, sponsorship, intervention and comparators, duration & outcome measures. RESULTS: A total of 197 AYUSH studies were registered on CTRI of which majority (n = 113) were from Ayurveda, with another nine of them with an intra-AYUSH collaboration. The highest number of studies were registered in month of June (n = 57). Maximum study sites were in Maharashtra (n = 65). From the 197 total studies, only six were observational studies, with 191 being interventional studies. As an outcome, majority of the studies aimed at recovery (n = 112). Majority of studies (n = 105) were Government of India sponsored and proposed in AYUSH setting (n = 107). The proportion of comparative studies was more than single arm studies. Guduchi (Tinospora cordifolia) was the most frequently mentioned drug. CONCLUSION: Our analysis revealed some interesting characteristics of the registered studies such as use of platform trial design, system specific criteria for assessment and personalized interventions. Though it was not possible to evaluate the quality of these studies in view of the limited dataset used for trial registration, we could notice variations in important characteristics like sample size, treatment arms, comparator used and study duration according to the primary aim of the studies. Overall, the present review underlines the formidable efforts of AYUSH sector in combating COVID-19 outbreak.