Adverse effect

Testosterone (patch)

DASS

Psychiatry

Developmental psychology

Anxiolytic

Anxiety

Placebo

Alternative medicine

Withania somnifera

Psychology

Rating scale

Internal medicine

Medicine

Traditional medicine

Randomized controlled trial

Pathology

Background: Ashwagandha ( Withania somnifera (L.) Dunal ) is a herb traditionally used to reduce stress and enhance wellbeing. The aim of this study was to investigate its anxiolytic effects on adults with self-reported high stress and to examine potential mechanisms associated with its therapeutic effects. Methods: In this 60-day, randomized, double-blind, placebo-controlled study the stress-relieving and pharmacological activity of an ashwagandha extract was investigated in stressed, healthy adults. Sixty adults were randomly allocated to take either a placebo or 240 mg of a standardized ashwagandha extract (Shoden) once daily. Outcomes were measured using the Hamilton Anxiety Rating Scale (HAM-A), Depression, Anxiety, and Stress Scale -21 (DASS-21), and hormonal changes in cortisol, dehydroepiandrosterone-sulphate (DHEA-S), and testosterone. Results: All participants completed the trial with no adverse events reported. In comparison with the placebo, ashwagandha supplementation was associated with a statistically significant reduction in the HAM-A ( P = .040) and a near-significant reduction in the DASS-21 ( P = .096). Ashwagandha intake was also associated with greater reductions in morning cortisol ( P &lt; .001), and DHEA-S ( P = .004) compared with the placebo. Testosterone levels increased in males ( P = .038) but not females ( P = .989) over time, although this change was not statistically significant compared with the placebo ( P = .158). Conclusions: These findings suggest that ashwagandha's stress-relieving effects may occur via its moderating effect on the hypothalamus-pituitary-adrenal axis. However, further investigation utilizing larger sample sizes, diverse clinical and cultural populations, and varying treatment dosages are needed to substantiate these findings. Trial registration: Clinical Trials Registry—India (CTRI registration number: CTRI/2017/08/009449; date of registration 22/08/2017)

An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract