Efficacy and Safety of Ashwagandha Root Extract Sustained-Release Capsules in Healthy Adult, Stressed Subjects: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Three-Arm Clinical Trial

Background/Objectives: The adaptogenic effects of Ashwagandha root extract are evident. An earlier study showed the therapeutic effects of a once-daily sustained-release (SR) formulation (300 mg) of Ashwagandha root extract over an extended period. This study aimed to evaluate the efficacy and safety of Ashwagandha root extract SR (AshwaSR) 150 mg and 300 mg capsules in reducing stress in healthy adult, stressed subjects. Methods: In this double-blind, randomized, placebo-controlled trial, healthy subjects with Perceived Stress Scale (PSS) score 14-26 were randomized (1:1:1) to AshwaSR 150 mg (group A) or 300 mg (group B) or placebo (group C). Change from baseline to day 60 was evaluated for stress levels, sleep quality, happiness level, eating behavior, and serum cortisol levels in all groups. Results: Of 135 subjects randomized, 126 completed the trial (mean age, 34.79±8.16 years). Mean PSS scores significantly reduced from baseline to day 60 in group A and B (mean change, 38.6% and 41.6% respectively; p<0.0001). Sleep quality, happiness level, and eating behavior significantly improved from baseline to day 60 in groups A and B (p<0.0001). Serum cortisol level in group B was significantly reduced at day 60 (p<0.05). Both group A and B showed significant improvement in stress levels, sleep quality, happiness level, and eating behavior at day 60 (p<0.05) compared to group C. No safety concerns were reported. Conclusions: AshwaSR 150 mg and 300 mg capsules reduced perceived stress and improved sleep quality, eating behavior, and happiness levels and were safe in healthy adult, stressed subjects over 60 days of administration.