Ayurveda formulation AYUSH 64 in asymptomatic and mild COVID-19 infection—A single-arm, open-label, prospective, pilot study

BACKGROUND: Coronavirus disease (COVID-19) pandemic has evolved as a unique, unprecedented global health crisis that has severely affected the economies and daily lives of people. AYUSH 64 is an Ayurveda formulation repurposed in the COVID-19 management because of its proven efficacy in influenza-like illness. MATERIALS AND METHODS: This was a prospective, open-label, single-arm, pilot study conducted at Ayurveda and Unani Tibbia College (A&U Tibbia) and Hospital, designated COVID-19 health center under the Government of National Capital Territory (NCT) of Delhi. The study population included 40 asymptomatic to mild COVID-19 cases of either sex aged above 18 years admitted to the hospital with positive nasopharyngeal swab test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (reverse-transcription polymerase chain reaction [RT-PCR]) or rapid antigen test. AYUSH 64 tablets in the dose of two tablets (500 mg each) thrice a day after food with warm water were given to the participants for the period of 7–14 days, and once the patient got RT-PCR negative, the medicine was discontinued. RESULTS: Out of 36 completed cases, 28 participants were symptomatic, 39.28% of participants clinically recovered in 7 days of AYUSH 64 intervention, and 53.5% of participants clinically recovered in 14 days. The mean time for clinical recovery was 7.04 days (±2.88 days standard deviation). No adverse drug reaction was found in any of the participants. Serious adverse event unrelated to the trial drug was reported in two participants (5%) within 24 h of enrolment. CONCLUSION: Among asymptomatic and mild COVID-19 cases, the repurposing of AYUSH 64 was found effective and quite safe to alleviate infection with a significant clinical recovery within 14 days. Subsequent research on a larger scale is warranted for statistically robust evidences in the treatment of COVID-19.