Ashwagandha ( <scp> <i>Withania somnifera</i> </scp> ) Root Extract Improves General Health in Elderly Men and Women: A Prospective, Randomized, Double‐Blind, Placebo‐Controlled, Efficacy and Safety Study

Ashwagandha (Withania somnifera), an adaptogen, is widely used in traditional Indian medicine for its health benefits in elderly people with functional limitations and physical disabilities. This double-blind, randomized, placebo-controlled clinical trial study assessed the efficacy and safety of a standardized Ashwagandha Root Extract (ARE) on general health improvement in elderly. Fifty (32 male, 18 female) healthy people aged between 60 and 85 years who consented to participate were randomly assigned to receive either capsule ARE 300 mg twice daily orally (n = 25) or an identical placebo (n = 21) for 8 weeks. The primary efficacy outcome was change in scores for Older People's Quality of Life (OPQOL) questionnaire, whereas secondary outcomes were change in scores for the Epworth Sleepiness Scale (ESS), and Senior Fitness Test (SFT). Clinical safety was evaluated using adverse events and global assessment of tolerability to therapy (GATT) by the physician. Greater improvement in OPQOL scores was observed with ARE, compared to placebo at both week 4 (p = 0.023) and week 8 (p < 0.0001), and these differences were observed in all sub-scales of OPQOL. Patients receiving ARE showed higher improvements after week 8 for total scores for ESS (p < 0.001), and SFT sub-scales (p < 0.01). The majority of participants on ARE reported excellent to good tolerability (96.0%). No adverse events were reported in the ARE group, while one patient reported nausea and headache in the placebo group. Ashwagandha root extract can be a useful herbal intervention for the improvement of general health and quality of life in elderly men and women.