ABSTRACT
An Ayurvedic polyherbal formulation (Ayush-64) was repurposed for use in mild to moderate COVID-19 cases based on the supportive evidence obtained from a pilot study on its effect on Influenza like illness (ILI) and molecular docking study which revealed that several compounds isolated from Ayush-64 demonstrated antiviral activity. The study aims at evaluating the effect of an Ayurvedic intervention (Ayush-64) in mild to moderate COVID-19 patients. A prospective single arm, pilot study in mild to moderate COVID-19 patients. The study was conducted at Chaudhary Brahm Prakash Ayurved Charak Sansthan (CBPACS), New Delhi, India. A total of 37 COVID-19 participants confirmed through RT-PCR were included in the study. The proportion 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 the secondary outcome. In the study, 86.1% of participants demonstrated clinical recovery with 14 days of use of Ayush-64 as stand-alone treatment without any other conventional medicines, out of which 75% clinically recovered within 8 days. Further, 69.4% of participants turned negative by the 15th day, out of which 50% became COVID-19 negative on the 8th day. No AE/ ADR was observed during the study. Ayush-64 may significantly facilitate clinical improvement in terms of duration for clinical recovery and attaining negative conversion in mild to moderate COVID-19 cases.
ABSTRACT
BACKGROUND: Influenza-like Illness (ILI) refers to a wide range of viral infections with an important cause of morbidity and mortality worldwide. The global incidence of ILI is estimated at 5-10% in adults and 20-30% in children. In India influenza accounts for 20-42% of monthly acute medical illness hospitalizations during the peak rainy season. AYUSH-64, a poly-herbal drug, is in practice for 40 years for various clinical conditions like fevers, microfilaremia, and inflammatory conditions. OBJECTIVE: A pilot study was conducted to evaluate the safety and efficacy of Ayurvedic formulation, AYUSH-64 in clinically diagnosed ILI for accelerating the recovery. MATERIAL AND METHODS: A prospective, open-label, nonrandomized, single group, single-center pilot clinical study with pre-test and post-test design was conducted at Raja Ramdeo Anandilal Podar Central Ayurveda Research Institute for Cancer, Mumbai, an institute of Central Council for Research in Ayurvedic Sciences (CCRAS) between June 2018 and July 2019. A total of 38 participants of clinically diagnosed ILI (18-65 years) were studied with an one-week intervention of 'AYUSH 64' in a dose of 3 gm/day and three weeks post-treatment observation period. Assessment of parameters viz. improvement in the symptoms of ILI, frequency of usage of acetaminophen, antihistaminic and cough syrup, hematology, liver function and kidney function tests along with incidence of secondary complications, and time to return to a normal routine was done. RESULTS: One-week intervention of AYUSH 64 helped to recover from ILI symptoms with reduced frequency of usage of acetaminophen and antihistaminic. The intervention was safe on hematology and biochemical parameters. No serious adverse effects were observed during the study. CONCLUSION: AYUSH 64 along-with standard care in ILI is safe and efficacious and this may be used in other viral infections with pyrexia as add-on to standard care for early recovery and better outcome.