Safety and efficacy of ayush rasayana A and B in improving functionality of the elderly – A single-arm multicenter study
Aparajit B Dey1, Inderjeet Singh Gambhir2, Jayram Hazra3, Sakshi Sharma4, Pallavi S Mundada5, Sunita Mata5, Avinash Chakrawarty1, Om P Singh6, Achintya Mitra3, Rakesh K Rana7, Richa Singhal6, SK Vedi8, Ramavtar Sharma5, Adarsh Kumar5, Bharti Gupta4, Madan M Padhi5, Narayanam Srikanth5, Kartar Singh Dhiman6
1 Department of Geriatric Medicine, All India Institute of Medical Sciences, New Delhi, India
2 Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pardesh, India
3 Central Ayurveda Research Institute, Central Council for Research in Ayurvedic Sciences, Kolkata, West Bengal, India
4 Department of Ayurveda, Central Ayurveda Research Institute, Central Council for Research in Ayurvedic Sciences, New Delhi, India
5 Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, New Delhi, India
6 Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pardesh, India
7 Department of Biostatistics, Central Council for Research in Ayurvedic Sciences, New Delhi, India
8 Department of Ayurveda, Regional Ayurveda Research Institute, Jaipur, India
Central Ayurveda Research Institute, Central Council for Research in Ayurvedic Sciences, Road No. 66, Punjabi Bagh, New Delhi - 110 026
Source of Support: None, Conflict of Interest: None
Background: As per Ayurvedic classics, Rasāyana is a term used for unique therapeutic measures intended to improve cognition, memory, physical strength and delay the degenerative processes. Ayush Rasayana A & B are developed from extracts of herbs pertaining rasayana property. Aims & Objectives: To assess the safety and effectiveness of 'Ayush Rasayana A and B' in improving physical endurance, quality of life and cognition of elderly. Materials and Methods: This is an open label, single arm, multi-centre study among 256 apparently healthy elderly between 60-75 years. Ayush Rasayan A was given for 6 days and Ayush Rayana B for 180 days. The effect of the trial drug was seen on functional capacity, quality of life and cognitive function and, safety of the intervention was assessed through haematological and biochemical tests, clinical examination and incidence of adverse events. Results: Significant improvement in 6 minute walk test and HMSE score was observed at 187th as compared to baseline (p<0.0001). Quality of life of the participants especially in domains of physical health, social relationship and environment also improved at the end of intervention period (p<0.0001). The haematological and bio-chemical parameters showed no significant changes as compared to baseline and no adverse events were observed during the study. Conclusion: Ayush Rasayana A and Ayush Rasayana B, both were well tolerated by all the participants. This ayurvedic intervention can be safely given to apparently healthy elderly to improve their functionality, quality of life and cognition. However, a randomized controlled trial is warranted to substantiate the efficacy of this drug.
Trial Registration: CTRI/2015/04/005679 dated 8th April 2015.