RCTJadad 5/5RandomizedDouble-BlindPlacebo-Controlled

Ashwagandha for Stress and Fatigue: What a Rigorous 12-Week Trial Actually Found

Journal of Psychopharmacology (Oxford, England)September 23, 2023Vol. 37 (11)

Summary

If you've seen ashwagandha marketed as a cure-all for stress, this study is a useful reality check. Researchers in Australia ran a well-designed, 12-week, randomized, double-blind, placebo-controlled trial in 120 overweight or mildly obese adults (ages 40–75) who reported both high stress and fatigue — a population that mirrors a lot of real-world supplement buyers, not just young, healthy volunteers. Participants took either 400 mg/day of a standardized ashwagandha root extract (Witholytin®, 1.5% withanolides, split into two 200 mg doses) or an identical placebo capsule.

The headline result is not what marketing claims usually suggest: on the study's primary outcome — perceived stress, measured with the well-validated Perceived Stress Scale (PSS) — ashwagandha did not beat placebo. Both groups improved substantially (about 39% vs. 36% reduction in stress scores), and the difference between them was not statistically significant (p = 0.867). That's a strikingly large placebo response, and the authors note it contrasts with earlier Indian trials where ashwagandha clearly beat a nearly flat placebo curve — a reminder that context, expectations, and even country of study can shape how "effective" a supplement looks.

Where ashwagandha did separate from placebo was on secondary measures. Self-reported fatigue (Chalder Fatigue Scale) dropped significantly more in the ashwagandha group (46% vs. 31% reduction, p = 0.016). Heart rate variability (RMSSD, a marker of parasympathetic "rest and digest" nervous system activity) rose non-significantly with ashwagandha but fell significantly in the placebo group, producing a significant between-group difference (p = 0.003) — suggesting a physiological, not just subjective, shift. In men, ashwagandha significantly raised free testosterone (+13%, p = 0.048) and luteinizing hormone (p = 0.016) relative to placebo, though levels stayed within normal ranges throughout. In women, estradiol rose 60% in the ashwagandha group versus a slight decline with placebo, though this didn't reach statistical significance (p = 0.137) — an exploratory subgroup hinted the effect might be concentrated in perimenopausal women. Other measures — general physical/mental wellbeing (PROMIS-29), sexual interest, blood glucose, HbA1c, total testosterone, DHEA-S, grip strength, and body measurements — showed no meaningful differences between groups.

Safety-wise, the extract was well tolerated: no serious adverse events, similar side-effect rates to placebo, and no concerning changes in liver, kidney, or blood count markers over 12 weeks.

Bottom line: this trial doesn't support "ashwagandha crushes your perceived stress" claims, but it does add credible evidence for anti-fatigue and autonomic nervous system effects, plus intriguing (preliminary) hormonal signals worth watching.

Sources: Verdure Sciences summary, Full study, PMC, 2025 meta-analysis: cortisol down, perceived stress not significant, 2024 systematic review on stress/anxiety

What This Means For You

For supplement shoppers: This trial used a specific, standardized extract (Witholytin®, hydroalcoholic, 1.5% withanolides) at 400 mg/day split into two doses — not a generic "ashwagandha" capsule of unknown potency. When buying, look for a standardized withanolide percentage on the label and a named, trademarked extract with published research (KSM-66, Sensoril, and Witholytin are the most-studied). Random bulk-powder capsules with no standardization may not replicate these results. Twice-daily dosing (morning and evening, with or without food) matches how this trial dosed it; effects took the full 12 weeks to fully manifest, so don't expect results in days.

Who might benefit most: People struggling more with fatigue/low energy and autonomic dysregulation (poor stress recovery, as reflected in HRV) than with subjective "feeling stressed" may see more benefit than those hoping specifically for a stress-score drop — this trial's stress benefit was matched by placebo.

For men interested in testosterone/vitality: The free testosterone and LH increases are notable but modest, stayed within normal physiological ranges, and were a secondary, exploratory finding — not grounds to expect dramatic strength, libido, or muscle-building effects. Sexual interest scores didn't improve significantly.

For women, especially perimenopausal: The estradiol increase is intriguing but underpowered and not statistically significant overall; it shouldn't be treated as a menopause therapy substitute.

Fitness angle: Grip strength and body composition markers (BMI, waist circumference) didn't change, so don't expect direct performance or physique effects from this dose/duration alone.

Cost-benefit: Ashwagandha is inexpensive and generally well-tolerated, so the risk of trying it for fatigue/recovery support is low — but temper stress-relief expectations against a strong placebo effect.

Important Considerations

This trial was well-designed (Jadad score 5/5: proper randomization, double-blinding, and dropout reporting), but several limits matter. The sample was narrow: overweight/mildly obese adults aged 40–75 with pre-existing stress and fatigue — results may not generalize to lean, young, or non-stressed individuals seeking "extra" benefits. Blood hormone analyses were split by sex, leaving only ~55–60 people per subgroup, which is underpowered to detect anything but large effects — several "trend" findings (MDA, estradiol) could be false negatives, false positives, or both, and should be treated as hypothesis-generating, not confirmatory.

The primary outcome (perceived stress) was negative — ashwagandha did not beat placebo here, despite what some marketing summaries emphasize about the fatigue and hormone findings. The unusually large placebo response (35% stress reduction) is itself a finding that deserves attention: expectancy effects, extensive questionnaire contact, and lifestyle attention during a 12-week trial can meaningfully reduce perceived stress independent of any active ingredient.

The study was funded by Verdure Sciences, the extract's manufacturer, and two of three authors have financial/professional ties to nutraceutical-industry research — a common but relevant conflict of interest in supplement trials. The MDA (oxidative stress) increase in men was unexpected and had high variability; it needs replication before concluding anything about pro-oxidant risk. Longer-term safety beyond 12 weeks, interactions with medications (thyroid, diabetes, psychiatric drugs were exclusion criteria here), and effects in pregnant/breastfeeding people remain unstudied. As always, talk to a doctor before starting ashwagandha if you're on thyroid medication, immunosuppressants, sedatives, or have liver conditions, given ashwagandha's documented effects on thyroid hormones and rare case reports of liver injury in the broader literature.

Terms Explained

AdaptogenA category of herbal substances (like ashwagandha, rhodiola, ginseng) believed to help the body resist and adapt to physical or psychological stress.
WithanolidesThe main active compounds in ashwagandha root, often standardized (e.g., to 1.5%) on supplement labels as a marker of potency.
Perceived Stress Scale (PSS)A validated 10-item questionnaire measuring how unpredictable, uncontrollable, and overloaded a person feels their life is; the primary outcome in this trial.
Chalder Fatigue Scale (CFS)An 11-item questionnaire assessing physical and mental fatigue symptoms like tiredness, low motivation, and poor concentration.
Heart Rate Variability (HRV/RMSSD)A measure of the variation in time between heartbeats; higher values generally reflect better parasympathetic ('rest and recover') nervous system function and lower stress load.
Free testosterone (FT)The small, biologically active fraction of testosterone not bound to blood proteins, often considered a more functional marker than total testosterone.
Luteinizing hormone (LH)A pituitary hormone that signals the testes or ovaries to produce sex hormones; used as an indirect marker of hormonal axis activity.
Malondialdehyde (MDA)A blood marker sometimes used to estimate oxidative stress (cell damage from free radicals), though its reliability is debated.
Intention-to-treat analysisA statistical approach that analyzes all randomized participants in their original assigned group, regardless of dropout, reducing bias from those who quit early.
Jadad scoreA 0–5 scale rating the methodological quality of a clinical trial based on randomization, blinding, and dropout reporting; this study scored a perfect 5.
Technical Study Details

Study Design

Duration12 weeks
RegistrationAustralian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621001551886

Total Score

JADAD Quality Assessment
5
/ 5

評価詳細

Randomization

2 / 2
Is the study described as randomized?
Yes+1
Rationale: The Methods section explicitly states the trial was "randomized, double-blind, placebo-controlled," and describes participants as "randomly allocated" to groups. This is reiterated in the Discussion section as well.
Is the method of randomization described and appropriate?
Yes+1
Rationale: The article describes a specific, appropriate randomization method: a randomization calculator was used to generate 12 randomly permuted blocks (10 participants per block, 1:1 ratio), ensuring sequence concealment. This is an appropriate randomization technique (akin to computer-generated randomization with block randomization), not an inappropriate method like alternation or allocation by date of birth/admission.

Blinding

2 / 2
Is the study described as double-blind?
Yes+1
Rationale: The article explicitly and repeatedly describes the trial as "double-blind" in the abstract, the Study design section, and the Discussion. Additionally, the methods describe blinding procedures (investigators and participants blind to allocation until data collection was complete) and an assessment of blinding efficacy, confirming the double-blind design.
Is the method of blinding described and appropriate?
Yes+1
Rationale: The article explicitly describes the blinding method: placebo and active capsules were identical in appearance (color, shape, size) and used the same excipient (cellulose), packaged in matching bottles with concealed codes held by the sponsor until data analysis. This is an appropriate double-blinding method consistent with Jadad criteria for a well-described, adequate blinding technique.

Dropouts/Withdrawals

1 / 1
Is there a description of dropouts and withdrawals?
Yes+1
Rationale: The article provides an explicit accounting of withdrawals/dropouts for each treatment group, including the exact number who withdrew (5 in ashwagandha, 4 in placebo) and the specific reasons for each withdrawal in both groups, satisfying the Jadad criterion for describing withdrawals and dropouts.

Study Population

Sample Size120
Age Range40-75 years
ConditionSelf-reported moderate-to-high stress (PSS ≥14) and fatigue (PROMIS-29 fatigue subscale ≥9) in overweight or mildly obese adults
Inclusion Criteria
  • Healthy males and females aged 40-75 years
  • Experiencing low energy/fatigue, based on a score of 9 or more on the PROMIS-29 fatigue subscale
  • Moderate-to-high stress, based on a score of 14 or higher on the Perceived Stress Scale (PSS)
  • Non-smoker
  • Body mass index (BMI) between 25 and 35 kg/m2
  • No plan to change diet or start new treatments during the study period
  • Willing to comply with all study procedures

Interventions

Ashwagandha root extract (Witholytin®)

Treatment
Dose200 mg per capsule (400 mg/day total)
Frequencytwice daily (morning and evening)
Duration12 weeks
Routeoral

Placebo

Control
Dose1 capsule
Frequencytwice daily
Duration12 weeks
Routeoral

Outcomes

OutcomeTypeEffectp-value
Self-reported adverse eventsSecondary--
Perceived Stress Scale (PSS) total scorePrimary-p = 0.867
Chalder Fatigue Scale (CFS) total scoreSecondary-p = 0.016Significant
PROMIS-29 Physical Health scoreSecondary-p = 0.642
PROMIS-29 Mental Health scoreSecondary-p = 0.626
PROMIS-29 Interest in Sexual Activity subscale scoreSecondary-p = 0.747
Total testosterone (TT)Secondary--
Free testosterone (FT)Secondary-p = 0.048Significant
EstradiolSecondary-p = 0.137
Luteinizing hormone (LH)Secondary-p = 0.016 (Results section); abstract reports p = 0.002 for this comparisonSignificant
Dehydroepiandrosterone sulphate (DHEA-S)Secondary--
Malondialdehyde (MDA)Secondary-p = 0.057
Fasting glucoseSecondary--
Glycated hemoglobin (HbA1c)Secondary--
Heart Rate Variability (RMSSD)Secondary-p = 0.003Significant
Grip strengthSecondary--
Body mass index (BMI)Secondary--
Waist circumference (WC)Secondary--
Waist-to-hip ratio (WHR)Secondary--

Safety

Serious AEs0
Dropout Rate7.5%
No serious adverse reactions reported. Similar frequency of adverse reactions in both groups. Three participants withdrew due to low/moderate severity self-reported adverse reactions believed related to capsule intake (ankle pain and reduced mood/tiredness in ashwagandha group; skin itchiness/rashes in placebo group). No adverse reactions reported by 78% of the ashwagandha group and 75% of the placebo group. No statistically significant between-group differences in changes in liver function, renal function, complete blood count, BMI, waist circumference, or waist-to-hip ratio.

Conclusion

Supplementing with 200 mg of ashwagandha extract (Witholytin®) twice daily for 12 weeks in overweight/mildly obese, high-stress, fatigued adults aged 40-75 was associated with significant reductions in perceived stress over time, but this reduction (PSS, primary outcome) was not significantly different from placebo (p=0.867). Secondary/exploratory outcomes showed ashwagandha significantly reduced self-reported fatigue (CFS, p=0.016) and increased heart rate variability (RMSSD, p=0.003) compared to placebo. In men, ashwagandha significantly increased free testosterone (p=0.048) and luteinizing hormone (p=0.016) versus placebo. No significant between-group differences were found for other self-report measures (PROMIS-29 physical/mental/sexual interest), DHEA-S, total testosterone, HbA1c, fasting glucose, or grip strength. Ashwagandha was well tolerated with no serious adverse events and no significant changes in safety blood markers or anthropometrics. Findings are preliminary and require confirmation in larger, adequately powered trials.

Limitations

  • Blood results were analyzed separately by sex, leaving only 60 men and 60 women, making the study underpowered to detect all but large treatment effects
  • Measurement frequency could have been improved by adding a midway (e.g., week 6) assessment
  • Only a limited number of biological markers were examined; future studies should include additional oxidative stress markers (e.g., myeloperoxidase, total antioxidant capacity) and inflammatory markers (e.g., CRP, TNF-alpha, IL-6)
  • Only indirect measures of HPA axis activation were used; future studies should include hair cortisol, diurnal salivary cortisol, cortisol awakening response, or experimental stress procedures (e.g., Maastricht Acute Stress Test)
  • Substantial variability in MDA concentrations at week 12 in the ashwagandha group means the MDA finding should be interpreted cautiously
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Ashwagandha for Stress and Fatigue: What a Rigorous 12-Week Trial Actually Found | Re:Vital Nexus