Ayurveda formulations for prophylaxis against coronavirus disease-2019 infection - A prospective community-based study in identified containment zones of 19 districts across India

Abstract

Abstract Background: The severe acute respiratory syndrome coronavirus 2 steady mutation lead to the desperate search for effective treatment and preventive measures for coronavirus disease-2019 (COVID-19) globally. Ayurveda describes various medications that have been recognized for their pharmacological properties, particularly immunomodulation and anti-viral properties. Objective: The objective of this study was comparative assessment of Guduchi Ghana Vati and Sudarshana Ghana Vati intake for the prophylaxis of COVID-19, with a control arm of standard prophylactic care in a population in a containment zone. Materials and methods: Communities having at least one confirmed case of COVID-19 were identified in 19 districts of India in 14 states. Twenty thousand healthy participants, irrespective of gender, in the intervention group and 10,000 healthy participants in the control group were enrolled from these selected communities through the Central Council for Research in Ayurvedic Sciences identified 15 institutes. Two tablets (250 mg each) of Guduchi Ghana Vati were given twice daily with warm water after food or two tablets (500 mg each) of Sudarshana Ghana Vati were given twice daily with warm water after food for 30 days in the intervention group and standard of care issued by central/state/local health authorities as part of standard preventive measure against COVID-19 was followed in the control group. The primary outcome measure of the study was the comparative assessment of the occurrence of COVID-19 infection in clinically stable participants in the community having at least one confirmed case already identified with the control arm of standard prophylactic care. The secondary outcome measures were a comparative assessment of the severity of COVID-19 infection in participants taking Guduchi Ghana Vati or Sudarshana Ghana Vati and the control arm by assessment of participants not requiring hospitalization, the severity of symptoms of hospitalized patients in wards and patients requiring intensive care unit admission/ventilator support, global assessment of overall change as per the investigator and safety assessment by the evaluation of occurrence of adverse event (AE)/serious AE (SAE) due to consumption of Ayurvedic intervention. A P value of < 0.05 was considered as significant. Results: The rate of COVID-19 positivity in the intervention group was 0.07% (n = 14) and in the control group was 0.04% (n = 4). Among 14 participants in the intervention group who tested COVID-19 positive, only one participant required hospitalization for management of COVID-19. The 4 participants who tested COVID-19 positive in the control group were hospitalized for management of COVID-19. After 30 days of intervention, the mean Immune Status Questionnaire (ISQ) score in the intervention group at baseline was 8.50, which increased to 9.16 on the 30th day (mean difference = 0.66), depicting the better immune status of the participants. Whereas, in the control group, the mean ISQ score at baseline was 8.68, which after 30 days reached 8.91 (mean difference = 0.23). No adverse drug reactions were reported in the study. Conclusion: Guduchi Ghana Vati and Sudarshana Ghana Vati were well tolerated and safe and showed potential benefits in the prophylaxis of COVID-19 in the participants. The study population is limited in representing people affected by COVID-19. Subsequent randomized controlled clinical research on diverse population may be undertaken to substantiate the prophylactic role of trial drugs in varied population.