Efficacy of polyherbal formulation along with standard care of treatment in early recovery of COVID-19 patients: a randomized placebo-controlled trial

Abstract

Abstract Background The coronavirus disease-2019 (COVID-19) pandemic crisis has affected millions of people worldwide. The emergence of mutant strains one after the other, breakthrough infections post-vaccination and reinfection of the virus have made it difficult to fight the pandemic and bring an end to it. Naturally available compounds with an array of phytochemicals and potent antiviral properties can provide an alternate solution in improving innate immunity, early recovery and symptomatic cure from COVID-19. Objective The present study investigates the efficacy of a polyherbal formulation, NAOQ19, on the rate of recovery and clinical improvement among COVID-19-infected patients who were not on a ventilator or in intensive care unit. Methods A randomized placebo-controlled study design was adopted for the study. The study enrolled 124 patients with 62 patients included in the NAOQ19 arm and other 62 patients enrolled in the placebo arm along with standard care of treatment. Key outcomes of the study included improvement from COVID-19 based on RT-PCR negative test tested on day 3, 5, 7 and 10, CRP inflammatory rate and drug safety. Data analysis included intention to treat approach. Significance was accepted with a two-sided p value < 0.05 for the outcome measures. Results The results of the present study demonstrated higher proportion of patients recovering in NAOQ19 arm compared to placebo arm on day 3 (33.8% vs. 8%; p < 0.001). The mean number of days required to turn RT-PCR (Real-time reverse transcriptase-polymerase chain reaction) negative was also lower in NAOQ19 arm by a day compared to placebo arm (5.4 vs. 6.2; p = 0.022). Inflammatory marker CRP (C-reactive protein) significantly reduced in the NAOQ19 arm at exit compared to placebo arm (6.25 mg/L vs. 10.26 mg/L; p = 0.048). Liver function test and kidney function test profiles were within normal limits during exit demonstrating the drug safety. Conclusion NAOQ19 along with standard care of treatment demonstrated higher percentage of population recovering from COVID-19 in comparison with those who were on standard care of treatment. Trial registration: The trial was also registered in Clinical Trial Registry India with registration number CTRI/2021/10/037423.