A prophylactic community-based study to assess the impact of Ayuraksha kit in COVID-19: A study Protocol of a cluster randomised trial

Abstract

BACKGROUND: The rise in the number of newly reported cases heralds the onset of the third wave of COVID-19 in India, despite the country’s relentless push for COVID-19 vaccination. In such a situation, efforts other than the vaccination, to strengthen the population’s immune system have become critical to keep the overburdened health-care system from being exhausted. Ayuraksha Kit includes four Ayurveda medicines viz., Chyawanprash, Samshamani Vati, Anu Taila and Ayush Kwath choorna. This kit is developed with an aim to enhance the general wellbeing and immunity of apparently healthy individuals. During the COVID-19 pandemic, this trial will investigate the impact of the Ayuraksha Kit as an adjunct to standard preventative measures in safeguarding people living in 12 Indian cities. MATERIALS AND METHODS: A community-based cluster randomized controlled trial will be conducted on 8316 apparently healthy adults. The clusters will be randomly allocated to two groups, intervention and control groups, in a 10:1 ratio. The advice on standard preventive measures along with masks and soaps for hand hygiene will be provided to all the study participants in both groups. Ayuraksha Kit will be given for one month to the 7560 study participants in the intervention group, and the 756 participants in the control group will be only given standard preventive measures. Effect of Ayuraksha Kit on incidence and severity of COVID-19 like symptoms and the psychological distress as an impact of risk of exposure to SARS CoV-2 will be assessed during this study. DISCUSSION AND CONCLUSION: As this study will be conducted in the areas predominantly resided by people belonging to scheduled castes in Indian cities, this cluster-RCT will determine whether the use of Ayuraksha Kit has a prophylactic potential against the incidence or on the severity of disease. TRIAL REGISTRATION: CTRI/2022/02/040156 dated 10th February 2022.