Abstract
Introduction During the COVID-19 pandemic in India, Ayurvedic medication (Guduchi Ghanavati, GG) was prescribed by Ayurveda physicians for prevention and management. This study aimed to evaluate the prophylactic effect of GG in individuals with moderate to very high risk of SARS-CoV-2. Methods A multicenter, controlled, quasi-experimental, before-and-after study was conducted on individuals at moderate to very high risk of SARS-COV-2 exposure. In the intervention group (n = 15,992), participants received GG 1 g daily for 28 days in conjunction with standard preventive guidelines (SPG), while in the control group (n = 4953), participants were asked to follow SPG only. Outcomes were the incidence of COVID-19, perceived immune status, quality of life, and safety. The perceived immune status was assessed using a brief Likert-scale questionnaire having common immune-related complaints. Results Of the 20,945 enrolled, 20,574 completed the trial (intervention: 15,729, control: 4845). The percentage of participants who reported the incidence of COVID-19 was marginally lower in the GG+SPG group (41, 0.26%) than in the SPG group (16, 0.33%), leading to 21% (95% CI, -40% to 55%) efficacy of GG. However, the decrease in incidence percentage was statistically insignificant due to the trivial incidences reported. The scores of perceived immune status quality of life improved significantly from baseline in the GG+SPG group (p < 0.001) compared to the SPG group. Conclusion GG is safe and improves perception of immune status in individuals at risk of developing SRAS-CoV-2. However, these findings are inadequate to establish that GG lowers the incidence of COVID-19 necessitating to conduct RCTs in high-risk populations. Clinical Trial Registration CTRI/2020/06/025,525.