Discussion
chronic co-morbid disorders, psychosocial disorders, pneumonitis, deaths, respiratory distress
PNEUMONITIS, DISEASE
This randomized controlled multicentric study showed that a combination regimen of AYUSH 64, a standard Ayurveda drug, and SOC was significantly superior to SOC in the treatment of mild and moderate COVID-19. 140 eligible participants were randomized for study intervention and monitored under direct physician observation in an in-patient COVID hospital setting. The 95% confidence interval of the difference in the mean duration (days) of clinical recovery (a-priori definition) from randomization baseline was—3.02 to—0.59 days (AYUSH 64 was well tolerated and found safe over 12 weeks of use in the dosage prescribed in the current study. There were no differences in the AE between the two study groups. AE were generally mild, and none caused the withdrawal of participants. Only 3 serious AE were reported (2 in SOC). 20 participants withdrew from the study and mostly after clinical recovery as per the personal preference not to continue in the study. There were no deaths in the study.Though enrolled with mild and moderate COVID-19, several participants in the current trial also suffered from chronic co-morbid disorders (COVID-19 is a dreadful disease with a huge burden of psychosocial disorders [More participants in the SOC arm showed definite radiographic pneumonitis (30% versus 19%) and failed resolution of radiographic abnormalities (85% versus 63%) at the time of clinical recovery/hospital discharge. One patient with mild radiographic disease in the SOC arm developed acute onset of progressive respiratory distress and required oxygenation and intensive care for recovery. All of this may suggest a more serious form of disease in the SOC arm, but this does not seem to be the case as shown by several other clinical variables, serum biomarkers, and overall clinical progress and response to standard of care treatment (Tables This study was exploratory in design and carried out during the first year of the pandemic. There were several concerns while the preparing the protocol. The pandemic and the stringent lock down imposed unique challenges for enrollment, physical and other examination, and monitoring of study participants. Our overall experience was consistent with that described recently in a report on drug trials in COVID-19 [