Methods
BLIND
The protocol was approved by the following Institutional Ethics Committee at each study site:-Institutional Ethics Committee, Datta Meghe Institute of Medical Sciences, Nagpur (No. DMIMS(DU)/IEC/2020/8785)Institutional Ethics Committee, Central Ayurveda Research Institute, Mumbai (No. 01/20-21)Institutional Ethics Committee, King George’s Medical University, Lucknow (No. 469/Ethics/2020).The study was a prospective, randomized, open label (assessor blind), parallel efficacy, two arm multicentric drug trial. The protocol was registered with the Clinical Trials Registry of India (CTRI) (registration number CTRI/2020/06/025557) [The overall scheme of the study, study procedures, and predetermined time points of evaluation are shown in 