RCTJadad 4/5RandomizedDouble-BlindPlacebo-Controlled

Adaptogen Blend vs. Pure Ashwagandha: What a New 60-Day Trial Found for Stress, Sleep, and Fatigue

TrialsFebruary 9, 2026Vol. 27

Summary

If you've stood in the supplement aisle wondering whether a "kitchen sink" adaptogen blend beats a straight ashwagandha capsule, a new 60-day randomized, double-blind, placebo-controlled trial (published in Trials, Feb 2026) offers some real data. Researchers in India enrolled 186 adults (67% women, average age 37) who scored in the "high stress" range on the Perceived Stress Scale (PSS) — think chronically overwhelmed, not clinically diagnosed with anxiety or depression. Participants were randomized 1:1:1 to one of three arms for 60 days: VL-G-A57, a Gaia Herbs blend of Rhodiola rosea, holy basil, milky oat, Schisandra, and ashwagandha; VL-G-E12, a full-spectrum ashwagandha-only extract; or a matched olive-oil placebo capsule. Neither participants nor researchers knew who got what, and a clever "double-dummy" trick (extra placebo capsules) kept the different dosing schedules from unblinding anyone.

The headline result: both real products beat placebo, and by a lot. PSS scores dropped by roughly 8-9 points in the treatment arms versus a much smaller placebo-arm change, a difference that was highly statistically significant (p < 0.0001) by day 60. For context, researchers have suggested a 2-3 point PSS drop might be clinically meaningful — so an 8-9 point reduction, while not formally validated as an MCID in this study, is a big shift. By the end of the trial, only 9-13% of people on the active products were still in the "high stress" category, compared with 56% of the placebo group.

The secondary outcomes tell a fuller story. Both products improved sleep quality (Pittsburgh Sleep Quality Index) and "restorative sleep" scores roughly twice as much as placebo, and cut fatigue (Fatigue Severity Scale) significantly. Anxiety scores (DASS-21) improved with both products; subclinical depression symptoms improved specifically in the multi-herb blend group. One outcome that did NOT budge: mental alertness — neither product beat placebo there, despite marketing narratives that adaptogens sharpen focus.

Interestingly, the two products weren't identical in their pattern of effects: the ashwagandha-only formula edged out on stress and sleep-quality speed, while the multi-herb blend showed more consistent, sustained mood benefits (anxiety and depression) through day 60. Both were well-tolerated — 11 mild adverse events total (headaches, colds), none deemed related to treatment, and no serious adverse events.

This adds to a fast-growing but still mixed evidence base on ashwagandha and adaptogens generally, where meta-analyses show consistent anxiety benefits but more debate over whether subjective "perceived stress" reliably improves versus just cortisol levels.

What This Means For You

For supplement shoppers: Both products were dosed at 350 mg capsules taken twice daily for 60 days — a realistic, buyable regimen (these are commercial Gaia Herbs products, VL-G-A57 marketed as "Adrenal Health Daily Support" and VL-G-E12 as a standalone ashwagandha extract). Look for standardization: VL-G-A57 was standardized to 4-6 mg eugenol and 6 mg total rosavins per serving; VL-G-E12 to at least 2.5 mg withanolides per serving. If a bottle on a shelf doesn't list standardized actives like these, you can't assume it matches what was studied — potency varies enormously across ashwagandha brands.

Timeline matters: Meaningful effects took 30-60 days to show up, not days. Don't expect an overnight fix; budget at least a month, ideally two, before judging whether it's working for you.

Who benefits most: This trial specifically enrolled people with elevated chronic stress (PSS 27-40) and sleep complaints — not the general population. If your stress is mild or you sleep fine, the effect size may be smaller or undetectable for you.

Blend vs. single herb: If sleep and fast stress relief are your priority, the ashwagandha-only formula performed slightly better/faster. If you're also managing low mood or anxiety over the longer term, the multi-herb blend showed an edge there. Neither improved mental alertness — don't buy either expecting a cognitive-focus boost.

Who should be cautious: People with existing sleep disorders, on psychotropic medications, pregnant/nursing, or with thyroid conditions were excluded from this trial and weren't studied — ashwagandha in particular can affect thyroid hormone levels and is generally advised against in pregnancy. Talk to a doctor before starting, especially if you take other medications or have a thyroid or autoimmune condition.

Important Considerations

This was an industry-funded trial: Gaia Herbs (the manufacturer) sponsored and supplied the products, and Vedic Lifesciences, India, facilitated the study — a conflict of interest worth flagging, though the trial was properly registered (ClinicalTrials.gov, CTRI) with prespecified outcomes and independent randomization, which limits some risks of bias. The Jadad quality score was 4/5, reasonably strong, docked mainly for not fully detailing per-arm dropout reasons in the text.

Generalizability is limited: everyone was recruited in India, two-thirds were women, and the age range topped out at 65 — results may not translate directly to other populations, diets, or genetics. The study measured perceived stress via questionnaire, not biological stress markers like cortisol or ACTH, so we don't know the underlying mechanism — the authors themselves call mechanistic explanations "speculative." That matters because other recent meta-analyses have found ashwagandha reliably lowers cortisol but doesn't always move the needle on self-reported stress — this study found the opposite pattern (big subjective improvement), which is a useful data point but not the final word.

No formal minimum-clinically-important-difference (MCID) analysis was done for the primary stress measure; comparisons to a "2-3 point meaningful change" benchmark from other literature are explicitly exploratory. Analyses used observed cases only (not a stricter intention-to-treat approach), which can slightly favor the treatment if dropouts differed systematically between groups. As with any supplement study, individual response varies — a 9-point average PSS reduction doesn't mean everyone will see it. If stress, anxiety, or insomnia are significantly impairing your life, see a healthcare provider rather than relying on supplements alone.

Terms Explained

AdaptogenA plant compound believed to help the body resist and recover from physical or mental stress by supporting the stress-hormone response system, rather than sedating or stimulating directly.

Perceived Stress Scale (PSS)A widely used questionnaire that scores how overwhelmed, unpredictable, or out-of-control a person has felt over the past month; higher scores mean more stress.

HPA axisThe hypothalamic-pituitary-adrenal axis — the body's central stress-response system that regulates cortisol release; chronic stress can dysregulate it.

WithanolidesThe main active compounds in ashwagandha root, used to standardize dosing so different products can be compared on potency.

Double-dummy designA blinding technique where participants on different dosing schedules all take the same number of pills — active plus matching placebo — so no one can guess their group from pill count alone.

Modified intention-to-treat (mITT) / observed casesA way of analyzing results using data actually collected from participants who completed assessments, rather than imputing values for people who dropped out.

Minimal clinically important difference (MCID)The smallest change in a score that patients or clinicians would consider meaningfully better, as opposed to a statistically significant but trivial change.

ANCOVA (analysis of covariance)A statistical test that compares group outcomes while adjusting for baseline differences, making it easier to isolate the treatment's true effect.

Restorative sleepThe subjective sense of waking up feeling refreshed and rested, distinct from simply how many hours you slept.

Technical Study Details

Study Design

RegistrationClinical Trials Registry - India (CTRI): CTRI/2022/11/047635

Total Score

JADAD Quality Assessment

/ 5

評価詳細

Randomization

2 / 2

Is the study described as randomized?

Yes+1

Rationale: The article repeatedly and explicitly describes the study as \"randomized\" (e.g., \"randomized, double-blind, placebo-controlled clinical study/trial\" and \"186 participants were randomized\"), satisfying the criterion for Q1.

Is the method of randomization described and appropriate?

Yes+1

Rationale: The article explicitly describes the randomization method as a computer-generated random sequence using block randomization (block size of six), generated by an independent statistician using validated software (StatsDirect). This is an appropriate and adequately described randomization method per Jadad criteria, as it ensures unpredictable allocation and is not based on inappropriate methods like date of birth, hospital number, or alternation.

Blinding

2 / 2

Is the study described as double-blind?

Yes+1

Rationale: The article explicitly and repeatedly describes the study as "double-blind" in both the abstract and the Methods/Study design section.

Is the method of blinding described and appropriate?

Yes+1

Rationale: The article explicitly describes the blinding method and it is appropriate: a matching placebo (olive oil capsules) identical in size, shape, color, and texture, packed in identical packaging, was used. Because the two investigational products had different dosing schedules (VL-G-A57: two IP capsules AM + two placebo PM; VL-G-E12: one IP + one placebo AM and PM), a "double-dummy" design was employed to maintain blinding across all three arms (two IP arms plus placebo). Participants, research staff, and investigators were all blinded to allocation. This constitutes a well-described and appropriate double-blinding method.</rationale> </invoke>

Dropouts/Withdrawals

0 / 1

Is there a description of dropouts and withdrawals?

No0

Rationale: The article only reports an aggregate total (186 randomized, 172 completed) without breaking down the number of withdrawals/dropouts by treatment group or stating the specific reasons for each in the text itself. The detailed disposition is referenced as being in Fig. 1 (CONSORT flow chart), but the actual per-group numbers and reasons for withdrawal are not provided in the article text, so this criterion is not satisfied.</rationale> </invoke>

Study Population

Sample Size186

Age Range18-65 years

ConditionChronic/high perceived stress

Inclusion Criteria

Age 18 to 65 years
BMI 18 to 29.9 kg/m2
Moderate levels of physical activity per IPAQ-SF
PSS score in the range of 27-40
RSQ-W score of ≤ 50

Interventions

VL-G-A57

Treatment

Dose350 mg per capsule

FrequencyTwo capsules in the morning (active) and two placebo capsules at night (double-dummy design)

Duration60 days

RouteOral

VL-G-E12

Treatment

Dose350 mg per capsule

FrequencyOne active capsule plus one placebo capsule in the morning, and one active capsule plus one placebo capsule at night (double-dummy design)

Duration60 days

RouteOral

Placebo

Control

Dose350 mg per capsule

FrequencyTwo capsules in the morning and two capsules at night

Duration60 days

RouteOral

Outcomes

Outcome	Type	Effect	p-value
Perceived Stress Scale (PSS) score	Primary	-	<0.05Significant
PSS stress-severity category shift (low/moderate/high)	Secondary	-	-
Pittsburgh Sleep Quality Index (PSQI) global score	Secondary	-	0.0008Significant
PSQI daytime dysfunction domain	Secondary	-	0.0231Significant
PSQI responder (≥3-point reduction in global PSQI score, MCID)	Secondary	-	-
Restorative Sleep Questionnaire-Weekly (RSQ-W) score	Secondary	-	<0.0001Significant
Mental Alertness score	Secondary	-	-
Fatigue Severity Scale (FSS) score	Secondary	-	0.0003Significant
FSS Visual Analog Scale (FSS-VAS) score	Secondary	-	0.0227Significant
DASS-21 Depression subscale score	Secondary	-	0.0454Significant
DASS-21 Anxiety subscale score	Secondary	-	0.0004Significant
DASS-21 Stress subscale score	Secondary	-	<0.0001Significant

Safety

Adverse Events11

Serious AEs0

Dropout Rate7.5%

All 11 adverse events were mild, assessed by investigators as unrelated to the study intervention, and resolved without sequelae. No serious adverse events were reported, and no participant discontinued due to adverse events. Vital parameters (blood pressure, pulse rate) remained within normal limits throughout the study.

Conclusion

Both VL-G-A57 (a Rhodiola, holy basil, milky oat, Schisandra, and ashwagandha blend) and VL-G-E12 (a full-spectrum ashwagandha extract) significantly reduced Perceived Stress Scale scores compared with placebo after 60 days in highly stressed adults, meeting the study's primary objective. Secondary outcomes also improved, including sleep quality (PSQI), restorative sleep (RSQ-W), fatigue (FSS/FSS-VAS), anxiety and, for VL-G-A57, subclinical depression (DASS-21), compared with placebo. Mental alertness did not differ significantly between groups. Both investigational products were safe and well-tolerated, with only mild, unrelated adverse events and no serious adverse events.

Limitations

Study conducted exclusively in India, with a majority of participants being female (~67%), which may limit generalizability to other populations, geographic regions, cultural contexts, or gender distributions
Molecular/mechanistic basis of the observed effects (e.g., HPA axis regulation, cortisol, ACTH) was not directly measured; mechanistic interpretations remain speculative
No formal MCID analysis was performed for the PSS; the exploratory comparison to literature-suggested clinically meaningful change (2-3 points) is not definitive
Analyses were performed using observed cases only, on the full analysis set