Safety and efficacy of Ayush 64 tablets as an adjunct therapy and its effect on bio- markers in mild to moderate covid-19 patients

Abstract

Background: COVID-19 has emerged as the latest pandemic that erupted in the Wuhan City of People’s Republic of China in December 2019, which is affecting human health and economy across the world. The ongoing COVID-19 outbreak in developed countries also highlights the fact that developed countries and rich populations are not immune to infectious disease outbreaks. Coronaviruses (CoVs) are enveloped, single-stranded, positive-sense RNA viruses that belong to the Coronaviridae family. SARS-CoV-2 is a member of the beta CoV genus, which also includes SARS-CoV-1 and MERS-CoV. The lack of approved effective drug therapeutic protocols for CoVs would make treating newly emerged COVID-19 infections globally difficult. Objective: A clinical study was conducted to evaluate the safety and efficacy of AYUSH 64 a poly herbal drug as an adjunct therapy to standard of care in mild to moderate Covid 19 patients Materials and methods: A prospective, open-label, randomized, parallel assignment, single-center clinical study with pre-test and post-test design was conducted at Covid hospital, Hassan institute of medical sciences between September 2020 to December 2020. A total 60 diagnosed cases (22-75 years of age) of Covid 19 were randomly allocated to both the groups. Control group received standard of care (SOC) as prescribed by the ICMR/WHO and state government, Trial Group received one week intervention of AYUSH 64 tablets at the dose of 2gm/day along with standard of care. Assessment of parameters viz. improvement in the symptoms, hematology, liver function, kidney function tests, acute phase reactants, Serum ferritin, Di dimer, LDH, and hsCRP were analyzed on day zero, day three and day seven. Results: One-week intervention of AYUSH-64 along with SOC helped to recover from Covid 19 symptoms. The intervention was safe on blood and biochemical parameters. Trial group has shown significant reduction in acute phase reactants viz hsCRP, LDH, Di dimer and Ferritin compare to the control group. No serious drug adverse effects were observed during the study. Conclusion: AYUSH-64 along-with standard care in mild to moderate covid 19 patients is safe and efficacious and this may be used as add-on to standard care for early recovery and better outcome.