Effect of an Ayurvedic intervention (Ayush-64) in mild to moderate COVID-19: An exploratory prospective single arm clinical trial

Abstract

Background: Ayush-64 is an Ayurvedic formulation, developed and patented by Central Council of Research in Ayurvedic Sciences (CCRAS). In the present study, we repurposed it for use in mild to moderate COVID-19 cases based on a pilot study against Influenza like illness (ILI) and molecular docking study which revealed that several compounds isolated from Ayush-64 demostrated antiviral activity. Purpose: To evaluate the role of Ayush-64 in clinical recovery of mild to moderate COVID-19 pattientsStudy Design: A single arm, pilot study in mild to moderate COVID-19 patientsMethods: The study was conducted from 20th June, 2020 to 11th August, 2020 at Chaudhary Brahm Prakash Ayurved Charak Sansthan (CBPACS), New Delhi, India involving 37 confirmed COVID-19 participants. Ayush 64 tablets in the dose of two tablets (500 mg each) thrice daily was given to the participants for a duration of either 8 or 14 days. Number of participants showing ‘clinical recovery’ was set as primary outcome. Percentage of participants with negative SARS-CoV-2 on nasal or throat swab in a 2-day consecutive real time RT-PCR test was evaluated as secondary outcome. Result: In the study 86.1% participants have shown clinical recovery after 14 days intervention of Ayush-64, out of which 75% clinically recovered within 7 days. Finding of RT-PCR test has shown that 69.4% participants turned negative till 15th day, out of which 50% became negative on 8th day. No AE/ ADR was observed during the course of the study.Conclusion: Ayush-64 is a safe treatment option in mild to moderate COVID-19 cases and is likely to significantly facilitate clinical improvement in terms of duration for clinical recovery and attaining negative conversion, without any ADR/AE.