Safety and efficacy of ashwagen (a standardized withania somnifera extract) in stress and anxiety with hypertension and associated cardiometabolic risk factors: a randomized, placebo-controlled trial

Clinical Snapshot

Key Findings

• P Value: Not reported

• Effect Size: Large effect sizes for anxiety reduction (>25% improvement)

• Primary Outcome: HAM-A reduced by 26.94%, GAD-7 by 50.77%, PSS by 30.47% versus placebo

• Nnt Or Sensitivity: Cannot calculate NNT without response rates or statistical significance data

• Confidence Interval: Not reported

Clinical Application

Oral supplementation twice daily is practical for primary care and specialist settings Not currently PBS-listed; would be private prescription or over-counter complementary medicine. Requires TGA approval for therapeutic claims. Aligns with RACGP guidelines supporting evidence-based complementary therapies as adjunctive treatment Adults with anxiety, stress, and hypertension seeking integrative treatment options

Abstract

Stress and anxiety are prevalent mental health conditions that often coexist with cardiovascular comorbidities, resulting in a complex interplay between psychological and physiological processes, partly mediated through activation of the hypothalamic-pituitary-adrenal (HPA) axis. Ashwagen®, a standardized extract of Withania somnifera (Ashwagandha), has demonstrated adaptogenic and anxiolytic properties in preclinical and clinical studies. This study aimed to evaluate the safety and efficacy of Ashwagen® in managing stress and anxiety in patients with pre-existing hypertension and associated cardiometabolic risk factors. A randomized, double-blind, placebo-controlled Phase III clinical trial was conducted over 60 days in 60 patients diagnosed with stress, anxiety, and pre-existing hypertension with cardiometabolic risk profiles. Participants received either Ashwagen® (300 mg capsule) or placebo twice daily. Efficacy assessments included validated psychological scales-Hamilton Anxiety Rating Scale (HAM-A), Generalized Anxiety Disorder-7 (GAD-7), Perceived Stress Scale (PSS), Clinical Global Impression-Improvement (CGI-I), Epworth Sleepiness Scale (ESS), and Fatigue Severity Scale (FSS)-along with serum cortisol, triglycerides, LDL, and blood pressure measurements. Ashwagen® significantly reduced anxiety and stress markers compared with placebo. HAM-A, GAD-7, and PSS scores decreased by 26.94%, 50.77%, and 30.47%, respectively, in the Ashwagen® group. Cortisol levels declined by 28.99% and triglycerides by 13.00%, with favorable trends in LDL and blood pressure. No serious adverse events were reported. Ashwagen® was found to be a safe and effective adjunctive integrative intervention for stress and anxiety management in patients with pre-existing hypertension.

References

1. 1.Pattojoshi, A., Patra, S. K., Idrees, S. A., Behera, S., Dalua, S. S., Tiwari, P., & Valavan, R. (2026). Safety and efficacy of ashwagen (a standardized withania somnifera extract) in stress and anxiety with hypertension and associated cardiometabolic risk factors: a randomized, placebo-controlled trial. Stress, Advance online publication. https://doi.org/10.1080/10253890.2026.2669544