Patient disposition and withdrawals: A randomized controlled study to evaluate the co-administration of AYUSH-64 with Standard of Care (SOC) in–mild-moderate symptomatic COVID-19 (CONSORT flow diagram).
SS
Electrocardiography was recorded during screening, hospital discharge, and on study completion.Standard skiagram of chest was carried out during screening, on clinical recovery/ hospital discharge, and during any follow-up visits if clinically indicated. The radiological evaluation described in the Data were collected on a daily basis during the hospitalization phase. Subsequently, after hospital discharge, it was collected during the predetermined follow-up schedule (4, 8, and 12 weeks) as shown in Data were recorded in the study case report forms at the point of care and later entered into a central electronic database using unique participant ID and study treatment code. The database was handled by pre-designated study team paramedics and locked after validation for any errors by the designated in-charge from CRO. Prior to the data analysis, a backup copy was provided to the sponsor by the CRO. Th database was unlocked and decoded by the study biostatisticians (SS, ST) prior to statistical analysis.