Ashwagandha
Withania somnifera
Also known as: Withania somnifera, Indian Ginseng, Winter Cherry, Ashwagandha Root, Withanolides
Evidence Strength: MODERATE
This ingredient receives a unclassified risk score due to safety concerns identified by health authorities in EU, Canada. Scientific evidence indicates ashwagandha is believed to modulate the hypothalamic-pituitary-adrenal (HPA) axis, reducing cortisol levels…. Reported adverse effects include gastrointestinal upset and diarrhea.
Safety Profile
Common Adverse Effects
- Gastrointestinal upset
- diarrhea
- drowsiness
- headache
- dry mouth
Serious Adverse Effects
- Hepatotoxicity
- allergic reactions
- thyroid dysfunction
Contraindications
- Hyperthyroidism
- autoimmune diseases
- pregnancy
- liver disease
- People taking Sedatives
Interactions
| Drug / Nutrient | Interaction Mechanism | Warning |
|---|---|---|
| Sedatives | additive effects — monitor for increased sedation. Thyroid medications: potential for altered thyroid hormone levels — monitor thyroid function. Immunosuppressants: possible interference — consult healthcare provider. | Monitor |
Evidence and Scientific Findings
Ingredient Overview
Biological and Chemical Classification
- Chemical Class
- Withanolide
- Biological Class
- Adaptogen
- Natural Source
- Withania somnifera root
- Scientific Name
- Withania somnifera
- Chemical Formula
- C28H38O6
- CAS Number
- 90147-43-6
Mechanism of Action
Clinical Evidence of Effectiveness
| Indication | Evidence Level | Summary |
|---|---|---|
| General | Moderate | Clinical studies on Ashwagandha suggest moderate efficacy in reducing stress and anxiety levels, with several randomized controlled trials showing significant improvements in cortisol levels and subjective stress scores. Evidence also supports its use in enhancing physical performance and cognitive function, although more large-scale studies are needed. The quality of evidence varies, with some studies lacking rigorous design. |
Pharmacokinetics
Recommended Dosage
| Condition / Use | Typical Dose |
|---|---|
| Stress reduction | 300-500 mg twice daily. Cognitive enhancement: 500-600 mg daily. Athletic performance: 500-1000 mg daily. |
Dosage ranges are based on clinical studies and commonly used supplement formulations. Individual requirements may vary.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Ashwagandha, scientifically known as Withania somnifera, is a traditional herb used in Ayurvedic medicine.
- Evidence consistency: High consistency across studies (100%)
- Ashwagandha is generally considered safe for most adults when used at recommended dosages. However, caution is advised in pregnant women due to potential uterotonic effects. Individuals with autoimmune diseases or thyroid disorders should consult healthcare providers before use. Regulatory agencies have not issued major warnings, but quality control of supplements remains a concern.
- USA/FDA — Approved
The available scientific evidence for Ashwagandha indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 11 აპრ 2026, 13:51
Evidence Distribution
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Observational / other LOW evidence YELLOWEffectiveness of Ayurvedic Nutritional Supplements and Yoga Protocol in Reducing the Incidence and Severity of Acute Mountain Sickness (AYAMS Study): Study Protocol… ↗Rai AK et al.. Effectiveness of Ayurvedic Nutritional Supplements and Yoga Protocol in Reducing the Incidence and Severity of Acute Mountain Sickness (AYAMS Study): Study Protocol for an Open-Label Randomized Controlled Trial.. JMIR Res Protoc. 2026. PMID:41950501.PMID 41950501 ↗Journal JMIR Res ProtocYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41950501/
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Observational / other LOW evidence YELLOWSafety of 8-Week Administration With Ashwagandha (Withania somnifera) Root Extract in Adults With Stress and Anxiety: Findings From a Prospective, Randomized, Multi-Center,… ↗Pakhale K et al.. 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.. Phytother Res. 2026. PMID:41943502.PMID 41943502 ↗Journal Phytother ResYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41943502/
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Observational / other LOW evidence YELLOWApoptosis Induction, Disruption of Cytoskeleton Remodeling and EMT Inhibition as Major Mechanism(s) Underlying the Pleiotropic Action of Withania somnifera in Breast Cancer. ↗Srivastava A et al.. Apoptosis Induction, Disruption of Cytoskeleton Remodeling and EMT Inhibition as Major Mechanism(s) Underlying the Pleiotropic Action of Withania somnifera in Breast Cancer.. Cytoskeleton (Hoboken). 2026. PMID:41943400.PMID 41943400 ↗Journal Cytoskeleton (Hoboken)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41943400/
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Observational / other LOW evidence YELLOWEffects of 8 days of Ashwagandha supplementation on strength, fatigue, soreness, and recovery in amateur handball players: A double-blind, randomized, placebo-controlled trial. ↗Ferreira JF et al.. Effects of 8 days of Ashwagandha supplementation on strength, fatigue, soreness, and recovery in amateur handball players: A double-blind, randomized, placebo-controlled trial.. Nutr Health. 2026. PMID:41940566.PMID 41940566 ↗Journal Nutr HealthYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41940566/
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Observational / other LOW evidence YELLOWDeciphering genotype and geography dependent microbiome composition and its role in disease suppression in Ashwagandha. ↗Bagul SY et al.. Deciphering genotype and geography dependent microbiome composition and its role in disease suppression in Ashwagandha.. Front Microbiol. 2026. PMID:41939697.PMID 41939697 ↗Journal Front MicrobiolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41939697/
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Observational / other LOW evidence YELLOWNew Vistas for Withania somnifera in Signal Transduction of Inflammation and Aging. ↗Sharma E et al.. New Vistas for Withania somnifera in Signal Transduction of Inflammation and Aging.. Pharm Res. 2026. PMID:41927962.PMID 41927962 ↗Journal Pharm ResYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41927962/
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Observational / other LOW evidence YELLOWExploring Phytoleads and Traditional Herbal Therapies: A Comparative Review on Stress Management. ↗Rathee S et al.. Exploring Phytoleads and Traditional Herbal Therapies: A Comparative Review on Stress Management.. Curr Pharm Des. 2026. PMID:41919431.PMID 41919431 ↗Journal Curr Pharm DesYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41919431/
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Observational / other LOW evidence YELLOWToxicological Assessment of LN20188, a Botanical Combination of Withania somnifera Root and Abelmoschus esculentus Fruit Extracts. ↗Madireddy R et al.. Toxicological Assessment of LN20188, a Botanical Combination of Withania somnifera Root and Abelmoschus esculentus Fruit Extracts.. Biomed Res Int. 2026. PMID:41914240.PMID 41914240 ↗Journal Biomed Res IntYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41914240/
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Observational / other LOW evidence YELLOWClinical evidence for the adaptogenic effects of Withania somnifera and Rhodiola rosea - Au00a0systematic review with molecular interpretation of psychometric outcomes. ↗u0141uszczak J et al.. Clinical evidence for the adaptogenic effects of Withania somnifera and Rhodiola rosea - Au00a0systematic review with molecular interpretation of psychometric outcomes.. Ann Agric Environ Med. 2026. PMID:41906501.PMID 41906501 ↗Journal Ann Agric Environ MedYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41906501/
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Observational / other LOW evidence YELLOWEfficacy and Safety of Herbal Supplements with Anxiolytic, Antidepressant, and Sedative Action: A Review of Clinical Data and Toxicological Risks. ↗Cu0103uu0219 MN et al.. Efficacy and Safety of Herbal Supplements with Anxiolytic, Antidepressant, and Sedative Action: A Review of Clinical Data and Toxicological Risks.. Pharmaceuticals (Basel). 2026. PMID:41901246.PMID 41901246 ↗Journal Pharmaceuticals (Basel)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41901246/
Score Transparency
1 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Very limited — minimal or very low-quality evidence
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Predominantly risk — strong adverse evidence in the literature
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
Multiple active safety or regulatory signals
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Ashwagandha. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a moderate safety concern. Caution is advised, particularly at high doses or in sensitive populations.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Moderate classification for Ashwagandha
A score of 5.0 places this ingredient in the Moderate band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
1 approved reference — more studies would increase the Q component toward 1.0.
Very limited — minimal or very low-grade evidence only.
Predominantly risk — strong adverse or warning signals dominate the reference set.
2 active signals (highest severity: High). Each active signal raises S above the neutral baseline of 0.5.
1 jurisdiction has active restrictions or advisories. Regulatory signals are recorded as Safety Signals and raise the S component.
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.