Effectiveness of Ayush Rasayana A and B on the Quality of Life of Older Adults:Protocol for a Cluster Randomized Controlled Trial

Background: With advancing age among older adults, the associated debilities increase, indicating a deteriorating health statusas there is a gradual loss of muscle mass, strength, and functionality. Ayush RasayanaA and B are coded Ayurvedic medicinesdeveloped from herbal extracts. This study has been planned to prevent debilitating conditions and improve the quality of life(QOL) in older adults. Objective: This study aimed to assess the effectiveness of Ayush RasayanaA and B on the QOL, quality of sleep, and functionalityof older adults, along with the tolerability of the intervention. Methods: This was a multicenter, open-label, cluster randomized controlled trial conducted with 720 participants aged 60 to75 years. The participants were divided into 2 groups (intervention and control), with both receiving Ayurvedic ancillary treatmentfor 3 months. The intervention group additionally received 10 g of Ayush RasayanaA orally once daily at bedtime for 6 days,followed by 1.5 g of Ayush RasayanaB orally twice daily before food for the remaining 84 days. The assessment criteria includedthe Older People's Quality of Life Questionnaire Brief, Katz Index of Independence in Activities of Daily Living, PittsburghSleep Quality Index, Five Times Sit-to-Stand Test, and shoulder and scapular movements. Any change in hematological andbiochemical parameters and occurrence of treatment-emergent adverse events were also assessed during the study period. Results: The recruitment of the participants started in December 2023, and the final follow-up was completed in April 2024.Out of the total 720 enrolled participants, 686 (95.3%) completed the study up to the last follow-up. Conclusions: This study may provide evidence-based data to establish preventive treatment protocols for enhancing the QOLand functionality among older adults. The study results may also be helpful for the planning of interdisciplinary health policiesfor improving the health conditions of different populations International Registered Report Identifier (IRRID): DERR1-10.2196/58186