Analysis of ayurvedic clinical trials registered in clinical trials registry of india: retrospective versus prospective registration

Abstract

Context: Registration of clinical trials is recommended at or before the first participant enrolment. There is limited data available on the registration of Ayurvedic clinical trials in Clinical Trials Registry of India (CTRI). Aim: The aim of this analysis was to determine the proportion of retrospectively and prospectively registered Ayurvedic clinical trials in CTRI. Methods: This was a cross-sectional analysis of Ayurvedic clinical trials registered in CTRI. List of trials registered in CTRI was accessed from 2012 to 2016 (n= 4713; last accessed on 21 June 2016) and screened to identify Ayurvedic trials. Other AYUSH trials were excluded from the analysis. Following data was collected - registration type (retrospective/prospective), study site (state), postgraduate thesis (yes/no), type of trial (interventional/observational), and study design. Data was summarized using summary statistics. Results: A total of 507 (10.8%) Ayurvedic trials were included in this analysis. The registration of Ayurvedic clinical trials increased from 9.3% (2012) to 19.9% (2016). Of 507 trials, 373 (73.6%) were registered retrospectively and remaining 134 (26.4%) were registered prospectively. A total of 277 trials were part of postgraduate theses (220 retrospective; 57 prospective) and 229 were not (152 retrospective; 77 prospective); 481 trials were interventional (357 retrospective; 124 prospective); 320 were randomized (236 retrospective; 84 prospective). The 507 trials had 686 sites, highest being in Gujarat (38.3%), followed by Maharashtra (19.2%), and Karnataka (10.1%). Conclusions: Results from this study showed that majority of Ayurvedic clinical trials have been registered retrospectively, however there is increase in prospective registration. More than half of the study sites of CTRI registered trials were located in Gujarat, Maharashtra and Karnataka reflecting limited registration in other parts of India.