Evidence map›Paper›PMID 41824889›Full record

Trial reportMedicine2026

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.

Shefali Thanawala, Rajat Shah, Krishnaraju Venkata Alluri, Kiran Bhupathiraju, Prabakaran Desomayanandanam, Arun Bhuvenendran

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Shefali ThanawalaMedical Science & Research, Nutriventia Private Limited, Mumbai, Maharashtra, India.ORCID 0000-0001-6887-0772
Rajat ShahExecutive Management, Nutriventia Private Limited, Mumbai, Maharashtra, India.ORCID 0000-0001-7170-8784
Krishnaraju Venkata AlluriPharmacology & Clinical Research, Laila Nutra Private Limited, Vijayawada, Andhra Pradesh, India.ORCID 0000-0002-0550-7164
Kiran BhupathirajuResearch & Development, Laila Nutra Private Limited, Vijayawada, Andhra Pradesh, India.
Prabakaran DesomayanandanamClinical Operations, In vitro Research Solutions Pvt Ltd, Bangalore, Karnataka, India.ORCID 0000-0001-9672-0181
Arun BhuvenendranStatistics & Data Analytics, In vitro Research Solutions Pvt Ltd, Bangalore, Karnataka, India.ORCID 0000-0002-3992-6957

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsIn 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.

resultsOf 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.

conclusionAshwaSR 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.

Indexed as

Plant ExtractsStress, PsychologicalWithaniaAdultCapsulesDelayed-Action PreparationsDouble-Blind MethodFeeding BehaviorFemaleHumansHydrocortisoneMaleMiddle AgedPlant RootsSleep QualitySubjective StressAshwagandhaCapsulesDelayed-Action PreparationsHydrocortisonePlant Extractsashwagandhapsychological well-beingsleepstresssustained-releasewithanolides

Identifiers

PMID41824889
PMCPMC12991725

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.