Randomization
Patients were randomized at each site to either of the two arms of a standard of care (SOC) or AYUSH 64 administered along with SOC (AYUSH plus) in a 1:1 ratio on a first come first serve basis. A central randomization schedule was prepared by the study biostatistician (SS) using standard statistical software (WINPEPI version 4.61 for MS Windows). Permuted block randomization was used in a group of 20 participants (strata of size 20) to ensure a number balance. The randomization schedule was provided online with restricted access to the site principal investigator.