Sleep

Effects of multi-herb and ashwagandha root formulas on stress modulation: a randomized, double-blind, placebo-controlled clinical study.

TL;DR

Both a multi-herb formula (Rhodiola, holy basil, Schisandra chinensis; VL-G-A57) and a full-spectrum ashwagandha formula (VL-G-E12) were associated with significant reductions in stress, fatigue, and anxiety while improving mood and sleep quality compared to placebo over 60 days.

Key Findings

Both adaptogen formulas significantly reduced Perceived Stress Scale (PSS) scores compared to placebo at day 60.

  • Both VL-G-A57 (multi-herb formula) and VL-G-E12 (ashwagandha) produced significant PSS reductions vs. placebo at day 60 (p < 0.0001 for both).
  • The study was a 60-day randomized, double-blind, placebo-controlled trial.
  • 186 participants were randomized across three arms: VL-G-A57, VL-G-E12, or placebo.
  • Efficacy was assessed by comparing mean changes using ANCOVA with baseline values as covariates, and Dunnett's post hoc test identified significant differences versus placebo.
  • Within-group changes were evaluated using paired t-tests; stress levels showed p < 0.0001 for both active arms.

Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) improved significantly in both adaptogen groups compared to placebo.

  • VL-G-A57 (multi-herb formula) showed significant PSQI improvement vs. placebo (p = 0.0008).
  • VL-G-E12 (ashwagandha) showed significant PSQI improvement vs. placebo (p < 0.0001).
  • Sleep quality was a secondary outcome measure assessed at days 30 and 60.
  • PSQI results corresponded with Restorative Sleep Questionnaire-Weekly (RSQ-W) findings.

Restorative sleep, as measured by the RSQ-W, improved significantly in both adaptogen arms compared to placebo.

  • Both VL-G-A57 and VL-G-E12 showed significant RSQ-W improvements vs. placebo (p < 0.0001 for both).
  • Restorative sleep was a pre-specified secondary outcome.
  • RSQ-W results were described as corresponding well with PSQI findings in both active intervention arms.

Anxiety was significantly reduced in both adaptogen groups compared to placebo.

  • VL-G-A57 showed significant anxiety reduction vs. placebo (p = 0.0004).
  • VL-G-E12 showed significant anxiety reduction vs. placebo (p = 0.0015).
  • Anxiety was a pre-specified secondary outcome measure.

Mood dysregulation was significantly improved in the multi-herb formula group (VL-G-A57) compared to placebo, but significance for VL-G-E12 on this measure was not reported.

  • VL-G-A57 showed significant improvement in mood dysregulation vs. placebo (p = 0.0454).
  • No p-value for mood dysregulation was reported for VL-G-E12 in the abstract.
  • Mood dysregulation was a pre-specified secondary outcome.

No significant differences in mental alertness were observed in either adaptogen group compared to placebo.

  • Mental alertness was a pre-specified secondary outcome that did not reach statistical significance for either active arm.
  • This was one of several secondary outcomes including sleep quality, fatigue, restorative sleep, mental alertness, mood dysregulation, and anxiety.
  • The abstract does not provide specific p-values for the mental alertness comparison.

The study enrolled adults aged 18–65 years with BMI 18–29.9 kg/m² and high stress levels, with sample size determined by a priori power analysis.

  • 186 participants were randomized to one of three arms: VL-G-A57, VL-G-E12, or placebo.
  • Eligibility criteria included age 18–65 years and BMI 18–29.9 kg/m².
  • Sample size was determined by a priori power analysis.
  • The trial was registered at ClinicalTrials.gov (NCT05602389) and the Clinical Trials Registry – India (CTRI/2022/11/047635), registered November 1 and 24, 2022 respectively.
  • Statistical analyses were conducted using R (v4.0.5) and XLSTAT (v2021.3.1); normality was assessed visually and via Shapiro-Wilk/Kolmogorov-Smirnov tests.

The study investigated two distinct plant-based adaptogen formulations targeting HPA axis-related stress modulation.

  • VL-G-A57 is a multi-herb formula containing Rhodiola, holy basil, and Schisandra chinensis.
  • VL-G-E12 is a full-spectrum ashwagandha root formula.
  • The rationale centered on chronic stress being detrimental to the hypothalamic-pituitary-adrenal (HPA) axis.
  • Both formulas were described as plant-based adaptogens.

What This Means

This research suggests that two herbal supplement formulas — one containing a combination of Rhodiola, holy basil, and Schisandra chinensis, and another containing full-spectrum ashwagandha root — can meaningfully reduce perceived stress, anxiety, and sleep problems in adults who report high stress levels. The 60-day study involved 186 participants randomly assigned to one of the two herbal formulas or a placebo, and neither the participants nor the researchers knew which treatment was being given until the study ended. Both herbal formulas outperformed placebo on the primary stress measure as well as on sleep quality and restorative sleep, with statistically strong results (p < 0.0001 in most cases). Anxiety also improved significantly in both groups, and the multi-herb formula additionally showed improvement in mood dysregulation. However, neither formula produced notable changes in mental alertness. This research suggests that both types of adaptogenic herbal preparations may offer complementary benefits for stress-related symptoms, with ashwagandha performing particularly well on sleep outcomes and the multi-herb formula showing an additional benefit for mood. These findings are notable because they come from a rigorously designed placebo-controlled trial with a pre-determined sample size, reducing some common risks of bias found in supplement research. The study was conducted over 60 days, providing some insight into effects beyond a very short-term window. For people experiencing high stress, this research suggests that these herbal formulas may be worth further investigation as supportive options, particularly for those who also struggle with sleep or anxiety. It is important to note that the study was industry-registered and that long-term safety, optimal dosing, and how these supplements interact with medications or other health conditions were not addressed in this abstract.

Have a question about this study?

Citation

McKinney E, Stewart J, Kewalramani R, Singh S. (2026). Effects of multi-herb and ashwagandha root formulas on stress modulation: a randomized, double-blind, placebo-controlled clinical study.. Trials. https://doi.org/10.1186/s13063-026-09495-9