Guduchi Ghanavati to Improve Immune Status and General Health in the Population at High Risk of COVID-19: Results of An Open-Label Non-Randomized Clinical Trial from India

Background: Ayurveda, the traditional system of Indian medicine, can offer prophylactic or therapeutic solutions for COVID-19. Govt of India recommended Guduchi Ghanavati (Ayurveda herbal formulation) as an Immunity enhancer and prophylaxis to SARS-CoV-2 during the COVID-19 pandemic. The study aimed to assess the effect of Guduchi Ghanavati as prophylaxis against SARS-CoV-2, as immunity enhancer and on Quality of life in adult volunteers who are at high risk of exposure to SARS-CoV-2. Materials & Methods: Non-randomized, multi-centric, controlled trial was conducted on the population of the community dwelling individuals having good health and were at moderate to very high risk of exposure to COVID 19 infection at five cities in Gujarat, India. Participants of the intervention arm received ‘Guduchi Ghana’ (GG) [extract of Tinospora cordifolia (Willd.) Miers] 1 g/day orally along with standard preventive guidelines (SPG) for SARS-CoV-2 infection (washing hand frequently, physical distancing, and covering the face). Participants of the control group followed standard preventive guidelines only. The outcome measures were the incidence of COVID-19, changes in Immune Status, WHOQOL-BREF, and preliminary safety. Results: a total of 41 incidences of COVID-19 were reported in GG+SPG group (n=15729 analyzed) whereas 16 incidences in SPG only group (n=4845 analyzed) indicating no significant association between the incidence of COVID-19 and Add-on GG intervention (OR, 0.79; CI, 0.44- 1.41 and Adjusted OR, 0.67; CI 0.37-1.21). Analyzing the effect on secondary outcomes, a significant difference (p<0.001) was reported in the mean score of immune status parameters (Immune score, Immune function, and general health) with the higher score in the GG+SPG group. Mean score changes for all four domains (Physical, Psychological, Social relationships, and Environmental) of QOL were also statistically significant ((p<0.001) in GG+SPG group compared to the standalone SPG group with a small effect size. No serious adverse event was reported in both groups. Conclusion: Data of the study supported the routine use of Guduchi Ghanavati to improve immune status and general health without any claim on COVID-19 as pre-exposure prophylaxis.