A Protocol for Effectiveness of Ayush Rasayana A & B on Quality of Life of Elderly Population: A Cluster-Randomised Study (Preprint)

BACKGROUND With advancing age amongst the elderly, the associated debilities increase, indicating a deteriorating health status as there is a gradual loss of muscle mass, strength, and functionality. The study has been planned to prevent debilitating conditions and improve the quality of life in the elderly population. OBJECTIVE To assess the effectiveness of Ayush Rasayana A & B on the quality of life (QOL), quality of sleep and functionality of the elderly population along with the assessment of the tolerability of the intervention among the elderly population. METHODS It is a multicenter cluster randomized study with a total sample size of 720, of age ≥60 to ≤75 years. Group I is being administered Ayush Rasayana A, 10 grams orally once daily at bedtime for the duration of 6 days followed by administration of Ayush Rasayana B, 1.5 grams orally twice daily before food for the consecutive 84 days. Group II is being given Ancillary care through Ayurveda for 3 months. The effectiveness and safety of the intervention is being assessed through haematological and biochemical parameters, clinical examination and incidence of adverse events. RESULTS The execution of the study has been initiated in April 2023. As of 29th February 2024, the enrolment of the participants for the study has been completed at all the designated study sites and follow up is being done at subsequent visits. 660 participants are continuing till date, while 13 participants have dropped out due to poor compliance. CONCLUSIONS The present study will assess the effects of Ayurveda interventions among the elderly populations The study findings will provide vital information that can be used to establish a preventive treatment to enhance the quality of life and functionality amongst the aged population. CLINICALTRIAL The trial is subsequently registered with the Clinical Trial Registry of India (CTRI/2023/06/054204) on 20th June 2023.