An 8-Week Oral Therapy with Ashwagandha (Withania Somnifera) Root Extract (600 mg/day) Improves Frailty and Quality of Life in Elderly: A Prospective, Randomized, Placebo-Controlled, Efficacy and Safety Study

Frailty is a state of increased vulnerability resulting from aging due to cumulative decline in physiological system over a lifespan. Few pharmacological agents have been investigated for the treatment of frailty. In Ayurveda, Ashwagandha (Withania Somnifera) is a popular botanical medicine used for improvement in physical strength and mental stress and has a potential for treatment of frailty. This placebo-controlled study assessed the efficacy and safety of a capsule containing 300mg of Ashwagandha Root Extract (ARE) administered twice daily orally for 8 weeks. Fifty elderly subjects with a frailty score [&ge;]7 based on Frailty Assessment and Screening Tool (FAST) were randomized in a 1:1 ratio to receive either Ashwagandha (ARE, n=25) or placebo (PL, n=25). Improvement in frailty after 8 weeks was assessed by FAST, 6-minute Walk Test (6MWT), Pittsburgh Sleep Quality Index (PSQI), Mini-Mental State Examination (MMSE) and Short Form Survey (SF-12) scores. Blood samples were collected at baseline and week 8 for estimation of C-Reactive Protein (CRP), cortisol and Creatinine Kinase (CK). Significant improvement (p<0.01) in scores for FAST, 6MWTs, PSQI, MMSE, and SF-12 were seen with ARE after 8 weeks. Also, significant improvements (p<0.05) were observed in CK and in CRP with ARE. These improvements were greater (p<0.05) with ARE as compared to placebo. ARE was well tolerated with no adverse effects, and no changes in hepatic and renal parameters. Thus, Ashwagandha root extract can be a valuable therapeutic option for improvement of health condition in frailty.