Efficacy and safety of Guduchighan Vati in asymptomatic and mild to moderate cases of COVID-19: A randomized controlled pilot study

Background: Currently, there is no approved treatment for the management of COVID-19 pandemic. Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19. Objectives: To determine the clinical effectiveness and safety profile of an Ayurveda Intervention (Guduchighan Vati) in asymptomatic and mild to moderate cases of COVID-19. Methods: This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19. Guduchighan Vati 500 mg twice daily for 10 days was administered in the intervention group as standalone therapy and Hydroxychloroquine in the control group. Outcome measures: Time to negative RT-PCR for COVID-19, proportion of participants turned RT-PCR negative for COVID-19 at 5th and 10th day, duration to achieve complete clinical recovery, improvement in laboratory parameters and incidence of Adverse Drug Reaction/Adverse Event. The data was compared within group using paired sample t-test/ Wilcoxon signed rank test and between group using independent sample t-test/Mann-Whitney test. The results of RT-PCR test was compared between group using chi-square test. Results: 93.3% participants turned RT-PCR negative for COVID-19 in the intervention group, as compared to 66.6% participants in control group till 10th day of the study period. However, the results are statistically insignificant (p = 0.068) which might be attributed to smaller sample size. All the symptomatic patients in the intervention group were clinically recovered at 5th day whereas 14 out of 15 recovered in the control group. No symptoms were observed at 10th day in both the groups. No adverse drug reaction/serious adverse event were observed during the study period. Conclusion: Guduchighan Vati is a safe and effective treatment for asymptomatic and mild cases of COVID-19 and it lowers the time to RT-PCR negative status without any adverse drug reaction/adverse event