Evaluation of an Ayurvedic formulation in clinical recovery of COVID-19 patients: A placebo controlled pilot study among moderate-severe patients
Abstract Introduction: The COVID-19 pandemic is a global health crisis that has affected millions of people worldwide. Apart from measures taken to reduce the transmission of virus and provide symptomatic relief to patients, a potent drug targeted against the virus is required to manage the disease. Traditional medicines with an array of phytochemicals and potent anti-viral properties, can provide alternate solution in the therapeutic cure of COVID-19.Objective: The present study investigates the efficacy of an Ayurvedic formulation, NOQ19, on the rate of recovery and clinical improvement among moderate-severe COVID-19 infected patients who were not on a ventilator or in intensive care unit.Methods: A placebo controlled randomized study design, with 1:1 ratio between the intervention and placebo arms was adopted. The participants were provided their respective intervention along with the standard of care treatment. A follow up was conducted on Day 7 and Day 10 to assess the rate of recovery and clinical improvement. Rate of recovery was the primary outcome measured and was determined by a negative result on the RT-PCR test. The secondary outcomes included clinical improvement among patients and were measured using blood biomarkers.Results: The NOQ19 arm had a higher percentage of population who turned RT-PCR negative on Day 7 (23%) when compared to the placebo arm (11%). Further subgroup analysis demonstrated that for both moderate and severe patients, there were a greater percentage of population who were RT-PCR negative in the NOQ19 arm compared to the placebo arm at Day 7: (NOQ-19: 22.22%, Placebo: 14.29% for moderate patients), (NOQ19: 23.08% Placebo: 0% for severe patients). By Day 10, both populations depicted an almost similar percentage of the population who were RT- PCR negative. Both the groups demonstrated an improvement in blood biomarkers, although the improvement was greater in the NOQ19 arm. None of the patients in the intervention arm reported any adverse events.Conclusion: The results of this pilot RCT indicates that NOQ19 along with standard of care treatment can be considered as an effective therapy for COVID-19 and aid early recovery from the disease.