Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush-64) add-on therapy for patients with COVID-19 infection (Stage I)-An Open labelled, Parallel Group, Randomized controlled clinical trial

COVID -19 has emerged as the latest pandemic affecting millions of the people world over. Many interventions are being tried to prevent and treat the same. Central Council for Research in Ayurvedic Sciences has developed a poly-herbal drug “AYUSH 64†which is considered to be effective in diseases like malaria, pyrexia of unknown origin, filariasis etc. This drug was found to be beneficial in influenza like illness and found to be safe in previous studies. This study was designed to explore its efficacy and safety of “AYUSH 64â€in COVID -19 patients having mild disease.

In this trial, we are going to enroll 30 confirmed COVID-19 patients having very mild disease in intervention and control group each. Intervention group will be given 2 capsules/tablets (500 mg each) every 8 hourly while control group will be on standard treatment as per the institution policy. The primary endpoint for this trial is “time to negative conversion of COVID 19†based on the report of RTPCR. Various secondary endpoints like duration of fever and respiratory symptoms, hematological parameters, adverse events, no. of patients referred, number cases requires oxygen therapy and no. of cases progressed to multiorgan failure will also be compared between intervention and control groups.