Safety and efficacy of herbal extracts to restore respiratory health and improve innate immunity in COVID-19 positive patients with mild to moderate severity: A structured summary of a study protocol for a randomised controlled trial

AbstractObjectivesPrimary Objective• To assess the efficacy of herbal extracts in boosting innate immunity of patients with COVID-19 infection.Secondary Objectives• To assess the efficacy of herbal extracts in restoring respiratory health• To assess the efficacy of Cap. IP in early recovery of patients and decline in viral load• To assess the safety of herbal extractsTrial designThis is a single centre, randomized, 2-arm, parallel group, double blind, 1:1 ratio, controlled, exploratory trial with a study period of 30 days from the day of enrolment.ParticipantsPatients attending the COVID treatment centre at Yashwantrao Chavan Memorial Hospital, Nehrunagar, Pimpri, Pune, India were screened for their participation in the study. Patients who were known COVID-19 positive (with positive RT-PCR), eligible and willing were enrolled in the study.Intervention and comparatorThe intervention in the trial has a background in ‘Ayurved’. Intervention Arm: Two capsules, Investigational Product (IP) - 1 - 400mg and Investigational Product - 2 - 450mg, containing herbal extracts (a blend of water and CO2 extracts) of Shunthi (Zingiber officinale (Ginger), Vidanga (Embelia ribes), Yashtimadhu (Glycyrrhiza glabra), Haritaki (Terminalia chebula), Guduchi (Tinospora cordifolia), Shatavari (Asparagus racemosus), Aamalaki (Emblica officinalis), Pippali (Piper longum) and calcined Zinc, Shankha bhasma.Placebo Arm: Edible starch ~ 450 mg. The look and feel of IP and of Placebo boxes were...
Source: Trials - Category: Research Source Type: clinical trials