Co-administration of AYUSH 64 as an adjunct to standard of care in mild and moderate COVID-19: A randomized, controlled, multicentric clinical trial

Abstract

Objective Evaluate the efficacy of AYUSH 64, a standard polyherbal Ayurvedic drug in COVID-19. Methods During the first pandemic wave, 140 consenting and eligible hospitalized adult participants with mild-moderate symptomatic disease (specific standard RT-PCR assay positive) were selected as per a convenience sample, and randomized (1:1 ratio) to an open-label (assessor blind) two-arm multicentric drug trial; standard of care (SOC as per Indian guidelines) versus AYUSH 64 combined with SOC (AYUSH plus). Participants were assessed daily and discharged once clinical recovery (CR, primary efficacy) was achieved which was based on a predetermined set of criteria (resolution of symptoms, normal peripheral oximetry, and negative specific RT-PCR assay). Each participant was followed using an indigenous software program(mobile phone) and completed a 12-week study period. The dose of AYUSH 64 was 2 tablets oral, 500 mg each, bid for 12 weeks (AYUSH plus only). Significant P was <0.05 (two-sided). On randomization, the groups were found well matched. Results The mean interval time from randomization to CR was significantly superior in the AYUSH plus group [mean 6.45 days versus 8.26 days, 95% Confidence Interval of the difference -3.02 to -0.59 (P = 0.003, Student’s ‘t test] as per-protocol analysis (134 participants); significant (P = 0.002) on an intention to treat analysis. 70% of the participants in AYUSH plus recovered during the first week (P = 0.046, Chi-square) and showed a significantly better change in physical health, fatigue, and quality of life measures. 48 adverse events, mostly mild and gut related, were reported by each group. There were 20 patient withdrawals (8 in AYUSH plus) but none due to an AE. There were no deaths. Daily assessment (hospitalization) and supervised drug intake ensured robust efficacy data. The open-label design was a concern (study outcome). Conclusions AYUSH 64 in combination with SOC hastened recovery, reduced hospitalization, and improved health in COVID-19. It was considered safe and well-tolerated. Further clinical validation (Phase III) is required. Trial registration CTRI/2020/06/025557.

A review on an ayurvedic antimalarial drug: Ayush-64

“…When used with SOC, Ayush-64 accelerated recovery, decreased hospital stays, and enhanced health in COVID-19 patients. It was deemed secure and well-absorbed [40] .…”

Ayurvedic Medicine: A Traditional Medical System and Its Heavy Metal Poisoning

“…5 Ayush-64, an Ayurvedic formulation used to treat malaria, has been repurposed as an adjuvant treatment for mild to moderate COVID-19. 7 Anu Taila, a traditional Ayurvedic compound used for intranasal administration, demonstrated preventive potential with strong antiviral effectiveness, viral load decrease, and virus entry barrier. 8 In a randomized controlled multicenter clinical trial, Withania somnifera ( Ashwagandha ) was found to be more effective and safer than hydroxychloroquine for COVID-19 prevention.…”

Evaluating therapeutic potential of AYUSH-64 constituents against omicron variant of SARS-CoV-2 using ensemble docking and simulations

“…Further it has been repurposed for the management of COVID-19 and has shown to be a significantly effective and safe adjunct in the treatment of mild and moderate COVID-19 in a prospective and randomized controlled drug trial. AYUSH 64 hastened clinical recovery, reduced hospitalization period, and showed early persistent health benefits with minimal/absent drug-related side effects ( Chopra et al, 2023 ). Incidentally in the large community study, Ayush 64 found to provide good therapeutic care to patients with asymptomatic, mild, and moderate COVID-19 in home isolation too ( Srikanth et al, 2022 ).…”