Sleep

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.

TL;DR

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.

Key Findings

Both doses of AshwaSR significantly reduced Perceived Stress Scale scores from baseline to day 60.

  • Group A (150 mg) showed a mean change of 38.6% reduction in PSS scores (P < .001)
  • Group B (300 mg) showed a mean change of 41.6% reduction in PSS scores (P < .001)
  • Both groups showed significant improvements compared to placebo group C at day 60 (P < .05)
  • Eligible subjects had baseline PSS scores of 14 to 26, representing moderate stress

Serum cortisol levels were significantly reduced in the 300 mg group at day 60.

  • Significant reduction in serum cortisol was observed in group B (300 mg) on day 60 (P < .05)
  • Cortisol reduction was not reported as statistically significant for group A (150 mg)
  • Cortisol was measured as a biomarker of physiological stress response

Sleep quality significantly improved in both AshwaSR dose groups compared to placebo.

  • Sleep quality improvements were significant from baseline to day 60 in groups A and B (P < .001)
  • Both group A and B showed significant improvements compared to placebo group C (P < .05)
  • The trial duration was 60 days

Psychological well-being significantly improved in both AshwaSR dose groups compared to placebo.

  • Psychological well-being improved significantly from baseline to day 60 in groups A and B (P < .001)
  • Both groups showed significant improvements versus placebo group C at day 60 (P < .05)
  • Subjects were described as healthy adult, stressed subjects

Eating behavior significantly improved in both AshwaSR dose groups compared to placebo.

  • Eating behavior improved significantly from baseline to day 60 in groups A and B (P < .001)
  • Both groups showed significant improvements versus placebo group C at day 60 (P < .05)
  • Eating behavior was one of the pre-specified outcome measures evaluated

The trial enrolled 135 subjects who were randomized and 126 completed the study.

  • 135 subjects were randomized 1:1:1 to AshwaSR 150 mg (group A), 300 mg (group B), or placebo (group C)
  • 126 subjects completed the trial
  • Mean age of participants was 34.79 ± 8.16 years
  • The study design was double-blind, randomized, placebo-controlled, parallel-group, 3-arm
  • Inclusion criterion required a Perceived Stress Scale score between 14 and 26

No safety concerns were reported with either dose of AshwaSR over the 60-day administration period.

  • Both 150 mg and 300 mg doses were described as safe in healthy adult, stressed subjects
  • No safety concerns were reported across either active treatment group
  • The safety observation period covered 60 days of administration

What This Means

This research suggests that a sustained-release formulation of Ashwagandha root extract (AshwaSR), taken once daily at either 150 mg or 300 mg, can meaningfully reduce feelings of stress in healthy adults who report moderate stress levels. After 60 days, participants taking Ashwagandha reported roughly 39–42% reductions in their perceived stress scores, along with improvements in sleep quality, psychological well-being, and eating behavior, compared to those taking a placebo. The higher 300 mg dose also produced measurable reductions in cortisol, a hormone the body releases in response to stress. The study was conducted as a rigorous double-blind, placebo-controlled trial with 126 participants completing the full 60-day period, which adds credibility to the findings. Importantly, no safety concerns were identified with either dose over the course of the study. This suggests that the sustained-release formulation may offer a well-tolerated option for managing everyday stress and its associated effects on sleep and behavior. This research matters because stress is a common issue that affects sleep, mood, and overall health, yet safe and effective options for managing it remain of broad public interest. The findings indicate that even the lower 150 mg dose was comparably effective to the 300 mg dose on most measures, though the 300 mg dose showed the additional benefit of reducing cortisol levels. These results build on earlier research into Ashwagandha's adaptogenic properties and provide dose-specific data that could inform future use of this formulation.

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Citation

Thanawala S, Shah R, Alluri K, Bhupathiraju K, Desomayanandanam P, Bhuvenendran A. (2026). 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.. Medicine. https://doi.org/10.1097/MD.0000000000047990