Download This PaperA Prophylactic Community Based Study to Assess the Impact of Ayu Raksha Kit in COVID-19 – Protocol of a Cluster Randomised Trial
16 Pages Posted: 14 Mar 2022 Last revised: 15 Mar 2022
Date Written: February 22, 2022
Abstract
Background: The upsurge in the number of newly reported cases heralds the approach of third wave of COVID-19 in India though the country has continued to drive COVID-19 vaccinations with utmost strength. In such situation, various measures, other than vaccination, to affect the immune system of the people positively also gain utmost importance to prevent the exhaustion of the overwhelmed health care system. Ayuraksha Kit which is a combination of four ayurvedic medicines viz., Chyawanprash, Samshamani Vati, Anu Taila and Ayush Kwath choorna which enhances the general wellbeing and immunity of apparently healthy individuals as per recommendation of Government of India.
Methods: To assess the impact of Ayuraksha Kit as adjuvant to standard preventive measures in protecting the people residing in mostly crowded and deprived areas of 12 cities in India, during COVID-19 pandemic, a cluster randomised community based controlled trial will be conducted on 8316 apparently healthy participants. In this study the said intervention will be given for one month to 7560 study participants. Standard preventive measures will be advised and masks and soaps for hand hygiene will be provided to all the study participants in both groups. 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: As this study will be conducted in the areas predominantly resided by people belonging to scheduled castes in Indian cities, the baseline survey regarding their health status, vaccination status and health seeking behavior can generate data about the impact of COVID-19 pandemic in the study population. The study results may indicate the impact of the said Ayurvedic medicines on immunity and overall health of people.
Note:
Funding Information: Central Council for Research in Ayurvedic Sciences (CCRAS), under Ministry of Ayush, Government of India, New Delhi has funded this study. [CCRAS Headquarters, 61-65 Institutional Area, Opp. D Block, Janakpuri, New Delhi 110058].
Conflict of Interests: The authors declare no competing interests. The authors are employees of Central Council for Research in Ayurvedic Sciences (CCRAS), a research organisation under Government of India.
Ethical Approval: The study has been approved by the Institutional Ethics committees of all the 12 study centres viz., Institutional Ethics Committee ARARI Chennai, Institutional Ethics Committee CARI Bangalore, Institutional Ethics Committee CARI Guwahati, Institutional Ethics Committee CARI Mumbai, Institutional Ethics Committee CARI New Delhi, Institutional Ethics Committee CARI, Bhubaneshwar, Institutional Ethics Committee NARIP Cheruthuruthy, Institutional Ethics Committee RARI Ahmedabad, Institutional Ethics committee RARI Trivandrum, Institutional Ethics Committee RARI Nagpur, Institutional Ethics Committee RARI Jaipur and Institutional Ethics Committee RARI Vijayawada. The eligible participants will be enrolled in the study only after obtaining their informed consent.
Trial Registration: The study has been registered prospectively in Clinical Trial Registry of India vide CTRI/2022/02/040156 on 10th February 2022.
Keywords: Ayurveda, COVID-19, India, Prophylaxis, SARS CoV-2
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