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Efficacy of Ayurveda intervention “Ayuraksha Kit” on COVID-19 incidence and outcomes: A prospective cluster randomized community-based study in India

BACKGROUND: Ayurvedic medicines have been used as preventative care and for managing COVID-19 in India from the early days of the pandemic. This study was conducted to evaluate the effectiveness of the Ayuraksha kit (ARK), a combination of four extensively used Ayurvedic interventions, as prophylactic care against COVID-19. OBJECTIVE: The primary objective was to observe the non-occurrence of COVID-19, and the secondary objective was to observe the changes in the general well-being and manifestation of COVID-19-like symptoms in the participants. MATERIAL AND METHODS: This was a prospective, open-label, multi-center, cluster randomized community-based study conducted from October 2020-March 2021 in India. A total of 153047 participants of either sex, aged 18 - 70 years, living in Scheduled Caste dominated areas of 18 identified states in India, were enrolled. The clusters from where at least one COVID-19 case was identified were randomized and allocated into two groups. In Group-I (n = 1,34,364), Ayuraksha Kit, which contains (Chyawanprash 6 gm once daily; Ayush Kwatha 75 ml once daily; Samshamani Vati 500 mg twice daily and Anu Taila one drop in each nostril twice daily) was administered for one month along with the standard preventive measures for COVID-19. In Group II (n = 18,683), only standard preventive measures for COVID-19 as per the existing guidelines were followed. RESULT: The proportion of participants who did not report having COVID-19 were significantly higher (98.9%)in the ARK group than in the control group (98.1%) after adjusting the history of contact with COVID-19 positive subject/contact with a person having COVID-19 symptoms. The proportion of participants with COVID-19 symptoms was slightly more in the control group. Among the COVID-19-positive cases, symptomatic cases were more in the ARK group, but the incidence of hospitalization (9.8%) was much lesser than that of the control group (12.5%). Improvements in general well-being (appetite, bowel, and sleep quality) were better in the ARK group than in the control group. The medicines in the ARK were well tolerated. CONCLUSIONS: ARK may be used for general well-being and as prophylaxis for preventing COVID-19 infection.