A methodological analysis of CTRI registered clinical trials on ayurveda interventions for COVID-19 management

Abstract

Abstarct: Background: Clinical trial protocols provide important methodological information and are expected to be detailed. During COVID-19 pandemic several studies has been registered on CTRI regarding ayurveda for COVID-19. However, there is accumulating evidence that many protocols do not address important study elements. Therefore it is critical to analyze the clinical trial protocols and methodology of ayurveda clinical trials regarding COVID-19 registered on CTRI. Objective: To assess the methodological aspects of CTRI registered ayurveda trial for COVID-19, based upon available trial protocols, during 2020 and 2021. Materials and methods: We searched the CTRI database for interventional trials protocols regarding ayurveda for COVID-19, during the year 2020 and 2021. We assessed the protocols for several methodological aspects such as study design, sample size, randomization, blinding, intervention (duration and type) and outcomes. Results: Total 140 clinical trial protocols were analyzed. The highest numbers of studies were registered in May, June, and July 2020 with steady decline thereafter despite rising COVID-19 cases. Total 90 trials were randomized and only 29 are blinded, however majority of the trials did not mention methods of randomization and blinding. Sample size in hospital-based studies ranged from 30 -500 and in community-based studies from 500-80000, however, sample size calculation details were not mentioned in the protocol. Most common intervention used were guduchi, ashwagandha, yashtimadhu, AYUSH-64, curcumin and chyavanprash. Conclusion: Although there was a surge of clinical trials on CTRI regarding ayurveda for COVID -19, the methodological quality is not up to the mark with large scope for improvement.

Keywords

• Ayurveda
• Clinical trials
• CTRI 4
• COVID-19
• SARS-COV 2