Therapeutic Response of Ayurvedic Preparation Raj Nirwan Bati on Severe COVID-19 Patients: A Double-Blind Randomized Placebo Controlled Clinical Trial

Background: The burden of present pandemic of COVID-19 is increasing exponentially day by day. There is a felt need for research on various treatment options available in the indigenous system of medicine. Ayurvedic (Indian system of medicine) preparations have been proven previously to be effective in many viral illnesses and play an important role in boosting the immunity of the human body. Aim and Objectives: To evaluate the therapeutic response of ayurvedic preparation RNB on severe COVID-19 patients. Methodology: A double-blind randomized placebo controlled clinical trial was conducted on 49 severely ill patients of COVID- 19 with one arm receiving RNB and the other placebo. Patients were evaluated on day-to-day basis and clinical improvement was assessed by a two-point reduction in patients’ admission status on a six-point ordinal scale. Results: Statistically significant (p=0.003) difference in proportion of conversion of Real Time Polymerase Chain Reaction (RT-PCR) result after six days of intervention was observed in both groups. The mean ± SD days required for the patients to become negative by RT-PCR test was shorter in RNB compared (10.1 ± 4.1 days) versus 14.4 ± 5.9 days in control group of patients and was found to be statistically significant (p=0.012). Average days to achieve two-point improvement on “sixpoint clinical improvement ordinal scale” was shorter in RNB group in comparison to placebo control group (7.9 ± 4.1 days versus 11.7 ± 4.7, p=0.009). The duration of hospital-stay and oxygen therapy required for management of COVID-19 cases was shorter in RNB intervention patients than in control group. Conclusion: Immunomodulatory, anti-inflammatory, anti-viral and broncho-dilatory properties in ayurvedic formulation makes RNB an ideal drug to act as an adjuvant to standard allopathic treatment against COVID-19 illness even in severely and critically ill patients in the present scenario.