Ayurveda formulation AYUSH 64 in asymptomatic and mild COVID 19 infection-A prospective, open label Clinical Study
Authors: Shamkumar Manoj , Shankar Shiv , Yadav Babita , Rajan Sujata , Jindal Nitin , Sharma Lalita , Rana Rakesh Kumar , Singhal Richa , Khanduri Shruti , Sharma Bhagwan S , Chandrasekhararao Bhogavalli , Srikanth N. , Bharti  , K.S.Dhiman  , Manchanda R. K. 
Published: August 2021

BackgroundCOVID 19 pandemic has evolved as a unique unprecedented global health crisis that has affected severely the economies and daily lives of people. Despite the diligent worldwide efforts to contain it, there is an exponential rise in cases. Associated serious morbidity and mortality has continued the efforts towards a clinically proven prophylaxis and therapeutic strategy. In the absence of any effective approved treatment, drug repurposing of available drugs are underway across the globe for treating COVID 19 patients. AYUSH 64 is an antimalarial Ayurveda formulation repurposed in COVID 19 management due to its proven efficacy in malaria and influenza like illness.Trial Design: This was a prospective, open-label, single-arm, pilot study conducted at Ayurveda and Unani Tibbia College(A&amp;U Tibbia ) and Hospital, Designated COVID-19 Health Center under Govt. of NCT of Delhi.Objective: The primary objective of the study was to assess the efficacy of AYUSH 64 in the management of asymptomatic, mild to moderate COVID-19 cases .However the secondary objectives were to assess clinical safety and to describe the clinical profile of COVID-19 with special reference to early symptoms, severity of disease, complications, course of disease, diagnostic investigations, biochemical &amp; imaging abnormalities and patterns of clinical recovery.Methods:The study was conducted on 40 patients out of which maximum were asymptomatic and mild COVID-19 cases of either sex aged above 18 years admitted in the hospital with positive naso-pharyngeal swab test for SARS-CoV-2 (RT-PCR ) or Rapid antigen test. Ayush- 64 tablets in the dose of two tablets (500 mg) thrice a day after food with warm water was given to the participants for the period of 7 to 14 days but once the patient got RtPCR negative ,medicine was discontinued. The primary outcome of the study was negative status of SARS-CoV-2 on nasal or throat swab after 07 days or 14 days of intervention in a 2-day continuous real time RT-PCR test and changes in liver enzymes &amp; renal functions. The secondary outcome of the study included the mean time (days) for clinical recovery as per clinical recovery criteria defined, number of symptomatic patients showing clinical recovery and improvement in selected laboratory parameters:, differential and total leukocyte counts, acute phase reactants, serum IL-6, Serological Protective Antibody Assay (IgE ,IgM and IgG).ResultsOut of 40 participants who were enrolled in the study, 36 (90%) completed the trial. Out of 36 participants, 69.44% participants after 07 days of AYUSH 64 intervention in the study became RT-PCR negative until 8th day and the rest 30.55 % participants completed the study in 14 days and they turned RT-PCR negative on 15th day. Out of 36 participants, 28 participants were symptomatic. 39.28% participants clinically recovered in 7 days of AYUSH-64 intervention and 53.5% participants clinically recovered in 14 days. 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 (SAE) was reported in two participants (5%) just another day after enrolment in the study, which was not related, to the trial drug and the same was informed to the sponsor.Conclusion Among asymptomatic and mild COVID-19 cases, the repurposing of AYUSH 64 was found efficacious and quite safe to alleviate infection with significant clinical improvement within 14 days. Subsequent research on larger scale is warranted for statistically robust evidences in the treatment of COVID-19.Trial Registration: CTRI/2020/05/025338- Clinical Trials Registry-India