Strengths and limitations
DISEASE
The study data was captured using a pragmatic protocol. Presuming a modest effect size, a sample size of 128 subjects was suggested [The confirmation of ‘Clinical Recovery’ (CR) in the current study may seem to be unduly subjective but was based on a pre-determined set of stringent criteria which included clinical and investigation measures (normal peripheral oximetry and a negative standard RT-PCR assay). Importantly, 48 hours of observation was mandatory to declare the resolution of symptoms and the total assessment was performed in a blinded manner. To the best of our knowledge, we did not find use of a similar set of criteria in any other interventional drug trial in COVID-19 during a search for relevant literature in the current study [There were other limitations that may have influenced the study outcome. Enrolment of subjects with early illness was a complex issue as was observed in several other COVID drug trials [We were concerned about the surreptitious use of Ayurvedic drugs in the current drug trial. Ayurveda drugs and other popular traditional home remedies were extensively used in India during the pandemic and AYUSH 64 was available in the market [The current study dealt with mild and moderate COVID-19 and no extrapolation of the outcome can be made to progressive and or severe disease. By the last quarter of 2020, the management of mild and moderate COVID-19 was rapidly shifted to a domiciliary or a quarantine facility in India [