Efficacy and safety of Ashwagandha root extract sustained-release (AshwaSR) capsules in healthy adult, stressed subjects: A randomized, double-blind, placebo-controlled, parallel-group, 3-arm clinical trial

Background: 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 sustained-release (AshwaSR) 150 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 score 14 to 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, psychological well-being, 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 Perceived Stress Scale scores significantly reduced from baseline to day 60 in group A and B (mean change, 38.6% and 41.6% respectively; P < .001). Sleep quality, psychological well-being, and eating behavior significantly improved from baseline to day 60 in groups A and B ( P < .001). Serum cortisol levels in group B were significantly reduced on day 60 ( P < .05). Both group A and B showed significant improvements in stress levels, sleep quality, psychological well-being, and eating behavior at day 60 ( P < .05) compared to group C. No safety concerns were reported. Conclusion: AshwaSR 150 and 300 mg capsules reduced perceived stress and improved sleep quality, eating behavior, and psychological well-being and were safe in healthy adult, stressed subjects over 60 days of administration.