NICEVIVA
MONOGRAPH SPEC LATEST 2026

Sensoril Ashwagandha

BOTANICALS · Evidence Monograph

Sensoril Ashwagandha is an evidence-graded botanicals monograph evaluated across 38 peer-reviewed PubMed studies (2 meta-analyses, 1 systematic reviews, and 14 randomized controlled trials, encompassing n = 2,822 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 38 Studies
Meta-Analyses · Reviews 2 Meta · 1 Systematic Reviews
Randomized Trials (RCT) 14 RCTs (14 Double-Blind)
Cumulative Participants n = 2,822
Reported Trial Dosages 500 mg/day · 500 mg · 300 mg
Trial Duration Range 12 weeks · 90 days · 8 weeks
Reading Time ~19 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 38 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (500 mg/day · 500 mg · 300 mg) over a structured 12 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (38 PubMed studies)
Quantitative biomarker & outcome analysis (18 studies with effect-size/sample data)
Randomized controlled trial verification (14 RCTs · 14 double-blind)
Systematic review & meta-analysis synthesis (2 meta-analyses · 1 reviews)
01

What Is Sensoril Ashwagandha & Why Does Form Matter?

Sensoril Ashwagandha is classified under BOTANICALS and has been investigated across 38 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (500 mg/day, 500 mg, 300 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Sensoril Ashwagandha frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (14 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Sensoril Ashwagandha acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Sensoril Ashwagandha an overall evidence rating of GRADE High (4.0 / 4.0) based on 38 PubMed studies: 2 meta-analyses, 1 systematic reviews, and 14 randomized controlled trials (14 double-blind, n = 2,822 total participants).

Representative peer-reviewed findings include: • PMID:30463324 (2018) — "Effects of an Aqueous Extract of Withania somnifera on Strength Training Adaptations and Recovery: The STAR Trial." (Conclusions: A 500 mg dose of an aqueous extract of Ashwagandha improves upper and lower-body strength, supports a favorable distribution of body mass, and was well tolerated clinically in recreationally active men over a 12-week resistance training and supplementation period.) • PMID:41987003 (2026) — "Safety Evaluation of an Aqueous Root and Leaf Extract of Ashwagandha (Withania somnifera)." (The data summarized in this report support the conclusion that Sensoril is not toxic or genotoxic.) • PMID:42053352 (2026) — "Formulation of Biscuits With Withania somnifera Root Powder: Polyphenols, Enzyme Inhibition, Antioxidant Capacity, and Acrylamide Formation." (Overall, it can be concluded that by incorporating ARP into the biscuit formulations allows for the production of functional biscuit while retaining the nutritional benefits of ARP.)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)SMD Effect Size & 95% CI DistributionEstimate (95% CI)PMID 41644067-5.88 (-8.15–-3.6)PMID 41140145-1.13 (-1.65–-0.6)-9.4Null (0)1.2Metric: SMD
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 500 mg/day · 500 mg · 300 mg · 3 mg/day over 12 weeks · 90 days · 8 weeks · 8 days. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Sensoril Ashwagandha, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (500 mg/day · 500 mg · 300 mg) and re-evaluate efficacy after 12 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (38 Studies) · 18 Quantitative Analyses

01
CLINICAL STUDY Nutrients (2018) PMID: 30463324 ↗
Effects of an Aqueous Extract of Withania somnifera on Strength Training Adaptations and Recovery: The STAR Trial.
Clinical Trial Synthesis 2018 Randomized Controlled Trial (RCT) published in Nutrients involving n = 19 participants; statistical significance reported at p = 0.009. Key conclusion: Conclusions: A 500 mg dose of an aqueous extract of Ashwagandha improves upper and lower-body strength, supports a favorable distribution of body mass, and was well tolerated clinically in recreationally active men over a 12-week resistance training and supplementation period.
View Original PubMed Abstract ↓

Withania somnifera (Ashwagandha) is an Ayurvedic herb categorized as having "rasayana" (rejuvenator), longevity, and revitalizing properties. Sensoril® is a standardized aqueous extract of the roots and leaves of Withania somnifera. Purpose: To examine the impact of Sensoril® supplementation on strength training adaptations. Methods: Recreationally active men (26.5 ± 6.4 years, 181 ± 6.8 cm, 86.9 ± 12.5 kg, 24.5 ± 6.6% fat) were randomized in a double-blind fashion to placebo (PLA, n = 19) or 500 mg/d Sensoril® (S500, n = 19). Body composition (DEXA), muscular strength, power, and endurance, 7.5 km cycling time trial, and clinical blood chemistries were measured at baseline and after 12 weeks of supplementation and training. Subjects were required to maintain their normal dietary habits and to follow a specific, progressive overload resistance-training program (4-day/week, upper body/lower body split). 2 × 2 mixed factorial ANOVA was used for analysis and statistical significance was set a priori at p ≤ 0.05. Results: Gains in 1-RM squat (S500: +19.1 ± 13.0 kg vs. PLA +10.0 ± 6.2 kg, p = 0.009) and bench press (S500: +12.8 ± 8.2 kg vs. PLA: +8.0 ± 6.0 kg, p = 0.048) were significantly greater in S500. Changes in DEXA-derived android/gynoid ratio (S500: +0.0 ± 0.14 vs. PLA: +0.09 ± 0.1, p = 0.03) also favored S500. No other between-group differences were found for body composition, visual analog scales for recovery and affect, or systemic hemodynamics, however, only the S500 group experienced statistically significant improvements in average squat power, peak bench press power, 7.5 km time trial performance, and perceived recovery scores. Clinical chemistry analysis indicated a slight polycythemia effect in PLA, with no other statistical or clinically relevant changes being noted. Conclusions: A 500 mg dose of an aqueous extract of Ashwagandha improves upper and lower-body strength, supports a favorable distribution of body mass, and was well tolerated clinically in recreationally active men over a 12-week resistance training and supplementation period.

02
CLINICAL STUDY Phytotherapy research (2026) PMID: 41987003 ↗
Safety Evaluation of an Aqueous Root and Leaf Extract of Ashwagandha (Withania somnifera).
Clinical Trial Synthesis 2026 Clinical Study published in Phytotherapy research. Key conclusion: The data summarized in this report support the conclusion that Sensoril is not toxic or genotoxic.
View Original PubMed Abstract ↓

Consumer interest in botanicals as part of their diet continues to grow with many options being offered, but the public health requirement for an understanding of potential toxicity underscores the need for safety data to be developed specific to each form (i.e., plant part and extraction method). Regulatory agencies require standard toxicology tests to be documented in the public domain to assist with the transparency of informed scientific review. For ashwagandha, despite a significant number of clinical studies, there is little publicly available toxicology data available to demonstrate safety of ashwagandha root and leaf products. We completed a broad range of older legacy but Organization for Economic Co-operation and Development (OECD) Test Guideline (TG)-compliant toxicology studies routinely recommended in regulatory safety guidelines specific to the aqueous ashwagandha root and leaf extract, Sensoril. The data summarized in this report support the conclusion that Sensoril is not toxic or genotoxic. No evidence of mutagenicity was observed in the in vitro Ames assay and Sensoril demonstrated negative findings in the in vitro micronucleus assay and in vivo mammalian bone marrow chromosome aberration assay, respectively. Sensoril was examined in rats at dose levels of 1000, 2000, and 4000 mg/kg/day over 90 days and did not exhibit mortality, morbidity, adverse clinical signs or produce test item related changes in weekly body weight, food consumption, ophthalmology, hematological or biochemical parameters. There were no test item related effects on thyroid hormones, sex hormones or microscopic pathology. The data from these studies support a no observed adverse effect level (NOAEL) of 4000 mg/kg/day in rats for an aqueous root and leaf ashwagandha extract. © 2026 Kerry group. Phytotherapy Research published by John Wiley & Sons Ltd.

03
CLINICAL STUDY Journal of food science (2026) PMID: 42053352 ↗
Formulation of Biscuits With Withania somnifera Root Powder: Polyphenols, Enzyme Inhibition, Antioxidant Capacity, and Acrylamide Formation.
Clinical Trial Synthesis 2026 Clinical Study published in Journal of food science. Key conclusion: Overall, it can be concluded that by incorporating ARP into the biscuit formulations allows for the production of functional biscuit while retaining the nutritional benefits of ARP.
View Original PubMed Abstract ↓

This study evaluated the application of Ashwagandha, Withania somnifera, root powder (ARP) at different levels 0% (B0 = control), 3% (B3), and 5% (B5) (W/W) in the production of biscuits as a popular snack. The results indicated that lightness increased, browning index decreased, and a significant reduction in pH was observed in these samples enriched. Compared to the control, acrylamide content (AAC) decreased in B2 and B3. Additionally, the nutritional value and the bioactive properties (total polyphenol content, α-amylase and α-glucosidase inhibitory activity, and antioxidant activity) of the enriched biscuit samples improved compared to the control. Overall, it can be concluded that by incorporating ARP into the biscuit formulations allows for the production of functional biscuit while retaining the nutritional benefits of ARP. PRACTICAL APPLICATIONS: In this study, an attempt was made to produce a biscuit that benefits from the nutritional and health-promoting effects of the root of the Ashwagandha, considering the health-promoting and antioxidant effects and the presence of bioactive substances in it, and due to the easy production and availability of biscuits for different segments of society; in addition, it can also respond positively to consumer demand for health-oriented products. It should be noted that if consumers are aware of the beneficial nutritional and health effects of plant food ingredients in food, it will be possible to accept even larger amounts of these functional additives in the final product. © 2026 Institute of Food Technologists.

04
RANDOMIZED TRIAL (RCT) Clocks & sleep (2026) PMID: 42029558 ↗
Comparative Evaluation of Ashwagandha (Withania somnifera) Root Extract and Melatonin for Improving Sleep Quality in Adults: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Clocks & sleep involving n = 50 participants; statistical significance reported at p = 0.0001. Key conclusion: Overall, both Ashwagandha and melatonin improved sleep disturbances in adults, with combination therapy producing the most consistent and pronounced benefits.
View Original PubMed Abstract ↓

Ashwagandha, a revered herb in Ayurvedic medicine for over 3000 years, is recognized for its potential benefits in regulating sleep and supporting overall vitality. This study evaluated the comparative effects of Ashwagandha root extract (ARE) and melatonin (MLT) on sleep quality in adults. In this prospective, randomized, double-blind, placebo-controlled trial, 200 men and women aged 18-50 years were randomized to receive ARE (300 mg twice daily; n = 50), MLT (3 mg/day; n = 50), a combination of ARE (600 mg/day) and MLT (3 mg/day; n = 50), or placebo (n = 50) for eight weeks. The primary outcome was the change in sleep onset latency (SOL) from baseline to week eight, measured by actigraphy. Secondary outcomes included actigraphy-based changes in total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE), as well as subjective measures such as the Pittsburgh Sleep Quality Index (PSQI) and the Hamilton Anxiety Scale (HAM-A). At week eight, SOL was significantly reduced across treatment groups, with the ARE-MLT (p < 0.0001) combination showing the greatest improvement. The combination group also demonstrated significant improvements in TST (p < 0.0001), WASO (p < 0.0001), and SE (p < 0.0001), whereas ARE and MLT monotherapy produced moderate but comparable benefits. Inferential analyses confirmed statistically significant improvements in objective and subjective sleep measures (p < 0.0001). Safety analyses indicated that mild adverse events occurred across all groups, with no clinically significant between-group differences. Overall, both Ashwagandha and melatonin improved sleep disturbances in adults, with combination therapy producing the most consistent and pronounced benefits.

05
CLINICAL STUDY Food science & nutrition (2026) PMID: 42005335 ↗
Withania somnifera Root Extract Ameliorates PTU-Induced Hypothyroidism by Regulating Hormone Levels and Gene Expression in Rats.
Clinical Trial Synthesis 2026 Clinical Study published in Food science & nutrition; statistical significance reported at p = 0.05. Key conclusion: Histopathology revealed reduced fibrosis and improved follicular architecture.
View Original PubMed Abstract ↓

Hypothyroidism is a prevalent endocrine disorder characterized by the inadequate production of thyroid hormones (T3 and T4), leading to various physiological dysfunctions. Current treatments often involve synthetic hormone replacement, which is limited by some adverse effects. This study investigated the therapeutic efficacy of a methanolic extract of Withania somnifera root (MEWS) in propylthiouracil (PTU)-induced hypothyroid rats. Forty rats were divided into five groups (n = 8): (1) negative control (NC), receiving no treatment; (2) positive control (PC), administered 0.05% w/v PTU to induce hypothyroidism; (3) W. somnifera control (WSC), treated with 500 mg/kg/day MEWS alone; (4) W. somnifera treatment (WST-500), receiving 500 mg/kg/day MEWS alongside PTU; and (5) combination therapy (CT-500), treated with both 500 mg/kg/day MEWS and 0.05% w/v PTU. Serum hormones (TSH, T3, T4) were measured by ELISA, thyroid histopathology was analyzed, and thyroperoxidase (TPO) and thyroglobulin (TG) gene expression were quantified by qPCR. Molecular docking and ADMET profiling were employed to identify bioactive phytochemicals that target the thyroid-stimulating hormone receptor (TSHR) and Type 2 iodothyronine deiodinase (D2). PTU induction significantly increased thyroid weight (175.8%), TSH levels (4.45-fold), and TPO/TG expression (4.28 and 3.10-fold), while reducing T3 and T4 (82% and 75%; all p < 0.05). MEWS treatment (WST-500) significantly reversed these effects, reducing thyroid weight (55.8%), TSH (74.2%), and TPO/TG expression, while restoring T3 and T4 levels to near-normal (p < 0.05). Histopathology revealed reduced fibrosis and improved follicular architecture. A computational study identified phytochemicals with strong binding affinities for TSHR and D2 and favorable ADMET properties. These findings suggest that MEWS may ameliorate hypothyroidism by regulating hormone levels, gene expression, and thyroid morphology, indicating its potential as an adjunct or alternative to conventional hormone replacement therapies for hypothyroidism. © 2026 The Author(s). Food Science & Nutrition published by Wiley Periodicals LLC.

06
CLINICAL STUDY Plants (Basel, Switzerland) (2026) PMID: 41977686 ↗
Cytotoxic Potential Evaluation of Innovative Pressurised Cyclic Solid-Liquid Extracts from Withania somnifera.
Clinical Trial Synthesis 2026 Clinical Study published in Plants (Basel, Switzerland). Key conclusion: Gene expression analysis revealed that 24-week-old plants exhibited the highest transcription of withanolide-biosynthetic genes, and drought stress significantly upregulated CAS, SMT1, DWARF1, CYP71, and CYP716, indicating enhanced metabolic flux toward withanol
View Original PubMed Abstract ↓

ETHNOPHARMACOLOGICAL RELEVANCE: Withania somnifera (L.) Dunal, widely used in traditional medical systems such as Ayurveda, Unani, and Middle Eastern folk medicine, is valued for its adaptogenic, anti-inflammatory, neuroprotective, antimicrobial, and anticancer properties. These activities are primarily attributed to withanolides, with Withaferin A recognized as one of the most bioactive constituents. Although traditional preparations often rely on the root, leaf use provides a more sustainable alternative and may yield significant quantities of active metabolites. Identifying efficient, modern extraction technologies that can enhance the recovery of bioactive compounds from leaves is essential for developing effective, standardized ethnopharmacological formulations. MATERIALS AND METHODS: Plants of W. somnifera grown from seeds were subjected to different environmental conditions (control, drought, cold, yeast extract treatment). Leaves were extracted using Pressurized Cyclic Solid-Liquid Extraction (PCSLE) with hydroalcoholic solvents and compared with conventional infusion of dried leaves. Extracts were fractionated with solvents of varying polarity and analyzed by TLC, HPLC, and NMR for quantification of Withaferin A. Expression levels of key withanolide-biosynthetic genes (CAS, SMT1, DWARF1, CYP71, CYP76) were assessed using qRT-PCR. Antimicrobial activity of pure Withaferin A, aqueous extract, and hydroalcoholic PCSLE extract was evaluated through MIC and MBC assays against Gram-positive and Gram-negative strains. Cytotoxic activity was measured via MTT assays in six human cancer cell lines after 3, 6, and 24 h of treatment. RESULTS: PCSLE yielded substantially higher levels of Withaferin A than traditional infusion, especially in medium-polarity fractions (chloroform and ethyl acetate), with concentrations reaching 0.70% in fresh leaf mass (4.8% dry weight), compared to 0.11% obtained by infusion. Gene expression analysis revealed that 24-week-old plants exhibited the highest transcription of withanolide-biosynthetic genes, and drought stress significantly upregulated CAS, SMT1, DWARF1, CYP71, and CYP716, indicating enhanced metabolic flux toward withanol

07
RANDOMIZED TRIAL (RCT) Phytotherapy research (2026) PMID: 41943502 ↗
Safety of 8-Week Administration With Ashwagandha (Withania somnifera) Root Extract in Adults With Stress and Anxiety: Findings From a Prospective, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled Study.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Phytotherapy research involving n = 1,002 participants; statistical significance reported at p = 0.487. Key conclusion: Tolerability ratings showed no statistically significant difference between the groups (p = 0.487), and most of the participants rated the ARE therapy as "Good" or "Excellent." ARE is well-tolerated and safe in adults with stress and anxiety.
View Original PubMed Abstract ↓

Ashwagandha (Withania somnifera) has been recognized for enhancing physical strength, mental well-being, and overall vitality. Despite its long-standing use across generations, some clinical reports have noted occasional adverse events. This study compared the safety and tolerability of Ashwagandha Root Extract (ARE) in healthy adults. This was a prospective, multicenter, multinational, randomized, double-blinded, placebo-controlled study (n = 1002; 18 to 65 years). Participants with reported stress and anxiety were randomly assigned to receive either 600 mg/day (two divided doses) of ARE (n = 498) or a placebo (PL, n = 504) orally for 8 weeks. The primary outcome was the safety profile assessed through laboratory parameters and adverse events (AEs), while tolerability was assessed by the participants on a 7-point Likert scale of Global Assessment of Tolerability to Therapy. Demographic and baseline characteristics were similar between groups. No serious adverse events were reported; a total of 74 AEs (7.4%) were documented, with 46 events (9.2%) in the PL group and 28 events (5.6%) in the ARE group. The most common AEs include nausea (3.2% in PL vs. 2.0% in ARE), dry mouth (1.4% in both groups), and headache (2.2% in PL vs. 0.2% in ARE). Laboratory evaluations showed no significant changes in liver function tests, renal function markers, or hematological parameters between the ARE and PL groups. Both groups maintained normal ranges for key biomarkers, including aspartate aminotransferase, alanine aminotransferase, creatinine, and hemoglobin levels throughout the study duration. Tolerability ratings showed no statistically significant difference between the groups (p = 0.487), and most of the participants rated the ARE therapy as "Good" or "Excellent." ARE is well-tolerated and safe in adults with stress and anxiety. These results support the use of Ashwagandha root extract as a viable non-pharmacological treatment, warranting further exploration of its long-term effects in diverse populations. © 2026 The Author(s). Phytotherapy Research published by John Wiley & Sons Ltd.

08
RANDOMIZED TRIAL (RCT) Nutrition and health (2026) PMID: 41940566 ↗
Effects of 8 days of Ashwagandha supplementation on strength, fatigue, soreness, and recovery in amateur handball players: A double-blind, randomized, placebo-controlled trial.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Nutrition and health; statistical significance reported at p = 0.011. Key conclusion: Perceived soreness, fatigue, and recovery did not differ meaningfully between groups.ConclusionsShort-term Ashwagandha supplementation may enhance handgrip strength, suggesting a potential neuromuscular benefit in athletes.
View Original PubMed Abstract ↓

BackgroundNutritional supplements are commonly used to increase strength, recovery, and overall athletic performance. Ashwagandha (Withania somnifera), a natural adaptogen, has shown promising ergogenic potential; however, evidence in athletes-particularly over short-term periods remains limited.MethodsThis randomized, double-blind, placebo-controlled trial investigated the effects of 8 days of Ashwagandha supplementation (600 mg of standardized root extract daily) - a duration chosen to evaluate its potential utility during acute competitive periods - on neuromuscular performance and recovery in 31 male handball players (age: 20.3 ± 3.1 years). Participants ingested either Ashwagandha (600 mg/day) or placebo capsules. Assessments included knee extension and flexion strength, handgrip strength, perceived muscle soreness, fatigue, and total quality recovery (TQR), measured at baseline, day 4, and day 8.ResultsAshwagandha significantly improved handgrip strength compared with placebo after 8 days (d = 0.33; p = 0.011), whereas no consistent effects were found for knee flexion or extension. Perceived soreness, fatigue, and recovery did not differ meaningfully between groups.ConclusionsShort-term Ashwagandha supplementation may enhance handgrip strength, suggesting a potential neuromuscular benefit in athletes. However, the lack of consistent effects on lower-limb strength and subjective recovery highlights the need for longer-term studies to confirm these findings.

09
CLINICAL STUDY BioMed research international (2026) PMID: 41914240 ↗
Toxicological Assessment of LN20188, a Botanical Combination of Withania somnifera Root and Abelmoschus esculentus Fruit Extracts.
Clinical Trial Synthesis 2026 Clinical Study published in BioMed research international. Key conclusion: Results of the bacterial reverse mutation assay showed that LN20188 did not exhibit a notable increase in colony count (mutagenicity) up to 5000 μg/plate.
View Original PubMed Abstract ↓

LN20188 is a botanical combination composed of extracts derived from Withania somnifera (L.) Dunal root and Abelmoschus esculentus (L.) Moench fruit. Our earlier investigations revealed the benefits of LN20188 in promoting gut motility and reducing constipation. The current investigation presents the toxicological profile of LN20188 following OECD guidelines for chemical testing. In an acute oral toxicity (AOT) study involving Sprague Dawley rats, no significant signs of toxicity or morbidity were observed, and the lethal dose (LD50) was determined to be greater than 2000 mg/kg body weight (b.w). Gross pathological findings further confirmed the safety of LN20188. In a repeated-dose subchronic toxicological investigation, rats were administered either 500, 1000, or 1500 mg/kg b.w of LN20188 for 90 consecutive days. LN20188 was found to be safe, where data on body weight, food consumption, organ weights, hematology, clinical biochemistry, and biomarkers were comparable to those of vehicle controls. The estimated no-observed-adverse-effect level (NOAEL) for LN20188 in male and female rats is determined to be 1500 mg/kg b.w. Genotoxicity studies, including bacterial reverse mutation, in vitrochromosomal aberration (CA), and in vivo micronucleus test (MNT) in mouse bone marrow erythrocytes, indicated no clastogenic or mutagenic activity. Results of the bacterial reverse mutation assay showed that LN20188 did not exhibit a notable increase in colony count (mutagenicity) up to 5000 μg/plate. In CA assay, LN20188 concentrations of up to 1000 μg/mL in the short term and 500 μg/mL in continuous exposure did not induce any chromosomal aberrations. Additionally, in vivo MNT showed that LN20188, up to 2000 mg/kg b.w, did not elevate the frequency of micronucleated PCEs (MNPCEs). Overall, these studies demonstrate that oral administration of LN20188 does not result in toxicity or genotoxic effects.

10
CLINICAL STUDY Frontiers in nutrition (2026) PMID: 41889719 ↗
A clinical assessment of the therapeutic effects of Ashwagandha root extract on cognitive performance, sleep, and fatigue in children aged 6-12 years.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Frontiers in nutrition involving n = 42 participants; statistical significance reported at p = 0.04. Key conclusion: CONCLUSION: These findings suggest that an eight-week supplementation with ARE is well tolerated and may enhance cognitive performance and sleep quality in children.
View Original PubMed Abstract ↓

INTRODUCTION: Ashwagandha (Withania somnifera L.Dunal) is an adaptogenic herb known to reduce stress and enhance well-being in adults. METHODS: This randomized, double-blind, placebo controlled, parallel-group trial evaluated the efficacy and safety of standardized Ashwagandha root extract (ARE) in children with parent-reported concerns related to attention, concentration, or memory. Eight-five healthy children aged 6-12 years were randomized to receive ARE gummies (n = 42; 150 mg twice daily) or identical placebo gummies (n = 43) for 8 weeks. Primary outcomes included attention, memory, and executive function assessed using the Computerized Mental Performance Assessment System (COMPASS). Secondary outcomes included overall functioning and well-being assessed using the Strengths and Difficulties Questionnaire (SDQ), Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2 Parent version), Sleep Disturbance Scale for Children (SDSC), and Patient-Reported Outcomes Measurement Information System - Fatigue Scale. Safety was evaluated based on self-reported adverse events. RESULTS: Among 73 participants who completed the study (ARE, n = 39; placebo, n = 34), ARE supplementation significantly improved speed of information processing (p = 0.040). Improvements were also observed in delayed word recall (p = 0.038, d = 0.59), Stroop task accuracy (p = 0.021, d = 0.61), Corsi block span (p = 0.013, d = 0.66), and choice reaction time accuracy (p = 0.005, d = 0.75). Additionally, SDSC scores improved, indicating better parent-reported sleep quality (p = 0.035). No significant adverse events were reported. CONCLUSION: These findings suggest that an eight-week supplementation with ARE is well tolerated and may enhance cognitive performance and sleep quality in children. CLINICAL TRIAL REGISTRATION: The trial was prospectively registered with the Clinical Trials Registry of India (CTRI/2021/10/037126; dated 06/10/2021; CTRI) and the Australian and New Zealand Clinical Trials Registry (Reg. No.: ACTRN12621000656831; ANZCTR-Registration).

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