A REVIEW OF CLINICAL STUDIES IN TUBERCULOSIS REGISTERED IN THE CLINICAL TRIALS REGISTRY OF INDIAAbstract
Background: Currently, 23 drugs for treating drug-susceptible TB, MDR-TB, or latent TB infection are in Phase I, II, or III trials. Bedaquiline, Delamanid and Pretomanid are new approved drugs. Still, TB is more prevalent in many countries. So, ideally, the countries facing this problem should do extensive research. Aim: The aim of our study is to find the number of studies, their design, sponsorship, phase, and state-wise distribution of studies on tuberculosis in India. Methods: After receiving an exemption from the ethics committee. The search term used in the “Trial Search” section of the CTRI site was “tuberculosis” or “TB” and the variables were captured and analyzed by using descriptive statistics in SPSS 26. Result: A total 134 studies were found. 61.9% of studies were interventional type, 78% were institute funded, 59 studies involved drug use mostly in combination, 104 studies were conducted at a single center, and 45 studies took sample sizes ranging up to 100. Only 37% of studies’ completion report was found. 18% of studies were on extrapulmonary tuberculosis. Conclusion: The majority of the studies were ongoing, randomized interventional, Institute-funded, single-centered pulmonary tuberculosis.
M. Prajapati * and Y. Shetty
Department of Pharmacology and Therapeutics, Seth G. S. Medical College & K. E. M. Hospital, Mumbai, Maharashtra, India.
09 March 2022
03 May 2022
28 May 2022
01 November 2022