Evaluation of covid-19 studies registered with the clinical trials registry of india [ctri] - a database analysis

ABSTRACT

Objective: To evaluate nature of COVID-19 studies registered with Clinical Trials Registry of India [CTRI]. Methods: An audit of all studies registered between March 2020 and January 2021 was done. We mined www.ctri.nic.in with keywords- 'COVID-19, SARS CoV2 and corona virus'. The variables considered for analysis were total number of studies, nature of study (interventional/observational), type (Allopathy/AYUSH/ Miscellaneous), source of funding (Pharmaceutical Industry/Government/ Institute/Self-funded), site (national/multinational and states in India), health category (patient/healthy human volunteer) and duration of the study. The comparison between the medicinal systems was done using the ANOVA. All analysis were done at 5% significance. Results: A total of N=1071 COVID-19 studies were registered. More than half were from the Miscellaneous category [for example behavioral, questionnaire-based studies]. A fourth of registered studies were from AYUSH followed by Allopathy which accounted for a fifth. Observational and interventional studies accounted for approximately 50% each of the total studies with the bulk belonging to the miscellaneous category. Amongst interventional studies, half were from AYUSH. Approximately 41% of these were funded by Ministry of AYUSH. A statistically significant difference was seen between the three medicinal systems [p <0.01]. Maximum studies were registered from Maharashtra (16%). Conclusion: Majority studies were registered from May to August 2020 and from Maharashtra. The AYUSH studies were maximally registered and their findings need to be urgently disseminated to guide policy for the country. © 2021 Journal of Association of Physicians of India. All rights reserved.