Ashwagandha (Withania somnifera) Root Extract Improves General Health in Elderly Men and Women: A Prospective, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study

Background and aim: Ashwagandha (Withania Somnifera), an adaptogen is widely used in traditional Indian medicine for its health benefits in elderly people with functional limitations and, physical disability. This double-blind, randomized, placebo-controlled treatment study assessed the efficacy and safety of Ashwagandha Root Extract (ARE) on improvement of general health in elderly. Experimental procedure: Fifty (32 male, 18 female) healthy people aged between 60 to 85 years who consented for participation were randomly assigned to receive either capsule ARE 300 mg twice daily orally (n=25) or identical placebo (n=21) for 8 weeks. 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 physician. Results: Greater improvement in OPQOL scores were observed with ARE, compared to placebo at both week 4 (p=0.018) and week 8 (p<0.001), 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-scale/total scores (p<0.01). Majority participants on ARE reported excellent to good tolerability (96.0%). One patient reported nausea and headache after three days after start of the study medication, while none were in ARE group. Conclusion and implications: Ashwagandha root extract can be a useful therapeutic option for improvement of general health and quality of life in elderly men and women