A proprietary herbal extract of ashwagandha root for stress and anxiety in healthy adults: a randomized, double-blind, three-arm, placebo-controlled efficacy and safety study.

Stress and anxiety are interconnected, sharing both behavioural and neural foundations. Ashwagandha (Withania somnifera) helps reduce stress and anxiety. This study aimed to evaluate the efficacy and safety of a proprietary herbal extract of ashwagandha root (APB) in adult men and women with moderate stress and anxiety. This 8-week, randomized, double-blind, three-arm, placebo-controlled trial included 141 healthy men and women aged 18-65 years with stress and anxiety. Participants were randomized to receive either 300 mg of APB twice daily (n = 47), ashwagandha root extract (ARE, n = 47), or placebo (PL, n = 47) for 8 weeks. The primary endpoint was a change in serum cortisol levels at week 8. Secondary endpoints were the mean changes in Perceived Stress Scale (PSS), Hamilton Anxiety Rating Scale (HAM-A), Profile of Mood States (POMS), and Oxford Happiness Questionnaire (OHQ) scores. Safety was assessed through clinical adverse events (AEs) and laboratory parameters. Between-group comparisons were analyzed using one-way ANOVA with Tukey's post-hoc test, and within-group changes were assessed using paired t-tests. At 8 weeks, all groups have shown a significant reduction in serum cortisol, and improvements in PSS (P < 0.0001), HAM-A (P = 0.001), and POMS domain scores (tension, depression, and anger, P < 0.0001). In addition, the APB showed significant differences compared with ARE and PL for PSS, HAM-A total score, OHQ, and POMS (P < 0.05). The proprietary herbal extract of ashwagandha root (300mg twice daily) is considered an effective and safe intervention for reducing stress and anxiety.