[Year:2020] [Month:July-September] [Volume:4] [Number:3] [Pages:7] [Pages No:128 - 134]
Introduction: In search of effective therapeutics or vaccines to treat or prevent coronavirus disease-2019 (COVID-19), various National Governments, World Health Organization (WHO), and associated partners are working on war footing to coordinate the rapid development of medical countermeasures by conducting various clinical trials. To date, several clinical trials, both Western and traditional medicines, have been registered in Clinical Trial Registry of India (CTRI). However, the relevant literature regarding clinical trials involving Ayurveda intervention on COVID-19 has not been published. In the current article, attempt has been made to extract, review, and summarize the relevant data regarding registered clinical trials under CTRI involving Ayurveda for COVID-19.
Materials and methods: CTRI has been searched comprehensively for the registered trials of COVID-19 involving Ayurveda Intervention from March 01, 2020 to June 25, 2020. For each study, the CTRI registration details, demographic characteristics, and study methodology including design are collected and summarized.
Results: Till June 25, 2020, a total of 58 trials were identified in CTRI, and of them 52 (89.66%) are interventional trials and 06 (10.34%) are observational trials. Majority of the registered trials are Government sponsored 39 (67.24%). Interventional prophylactic trials were found to be registered in equal proportion to the interventional therapeutic trials (26 each of the total 52 registered interventional trials). Majority of trials are controlled (35, 60.34%), and the allocation of participants into treatment or controlled groups is done by randomization in (24, 41.37%) of controlled trials. The maximum proportions of trials are open-label trials (47, 81.03%), and only three trials are double-blind placebo-controlled trials. All the intervention prophylactic trials are standalone (26, 100%); however, majority of the intervention therapeutic trials are adjunctive (17, 65.38%) to standard of care (conventional medicine). Interventional agent in most of the trials is either multiple drug combinations (23, 44.23%) or compound drug formulations (21, 40.38%) compared to single drug administration (8, 15.38%).
Conclusion: The article provides an insight into the CTRI registered trials involving Ayurveda and COVID-19 till June 25, 2020. Although certain issues have been observed related to the design of trials, however, the efforts put in by various stakeholders of Ayurveda, especially Ministry of AYUSH is laudable. Once completed, the results of these promising studies should be published at the earliest, and accordingly the policy makers from Traditional system of medicines should strategize effective solutions to benefit public health in these challenging times.