Safety of 12-Months Administration of Ashwagandha ( Withania somnifera ) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study.

Abstract

Ashwagandha, an adaptogen, is an important herb of Ayurveda used as a Rasayana for its various health benefits. This prospective, multi-center, observational clinical study evaluates the safety (clinical and laboratory) of a standardized Ashwagandha Root Extract (ARE) on long-term administration over 12 months. Male and female adults (N = 191) aged between 18 and 65 years were included in the study. Clinical assessments were done at baseline, followed by monthly for 12 months, whereas laboratory and other study assessments were done at baseline, 6 and 12 months. The primary outcome was the clinical adverse events reported by the patients, whereas secondary outcomes were Clinical Global Impression-Improvement scale (CGI-I), health-related Short Form-12 Quality of Life (SF-12 QoL), and laboratory estimations of serum for cortisol, hepatic, renal, and thyroid function. ARE administration for 12 months reported 18 mild adverse events, which were resolved without intervention. The study reported no clinical significant changes in serum alanine transaminases (baseline: 31.31 ± 9.28 IU/L, end of study: 33.68 ± 6.80 IU/L), aspartate transaminases (baseline: 30.61 ± 7.18 IU/L, end of study: 29.02 ± 4.63 IU/L). Serum cortisol levels decreased significantly (p < 0.001), while lipid profile and plasma glucose levels remained unaffected. Serum testosterone (free and total) significantly increased (p < 0.05). SF-12 scores demonstrated significant improvements at 12 months (p < 0.001), indicating enhanced health-related quality of life. CGI assessment indicated overall improvement in 68.7% of patients, particularly notable in those aged ≥ 50 years. This study validates the long-term safety of ARE use over 12 months. Trial Registration: ClinicalTrials.gov identifier: CTRI/2022/10/046180; NCT06244147.