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
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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