Summary
Ashwagandha has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Anxiety Disorders. ClinicalTrials.gov lists 5 registered trials linking Ashwagandha to Anxiety Disorders: 2 are currently recruiting; 1 is active or not yet recruiting; 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT01311180). It plans or enrolled 120 participants. Registration activity spans 2011 to 2026. The literature layer holds 7 publications for this pair: 2 Cochrane reviews, 1 meta-analysis, 2 systematic reviews and 2 clinical trial publications. Publication years run from 2014 to 2023. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Anxiety ranks 535 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: GAD: spontaneous remission in ~25-30% at 1 year without treatment; social anxiety: 36% remission at 12 years untreated; panic disorder: 50-65% spontaneous partial remission but relapse common; 40-60% remain symptomatic at 5 years.
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 42.0 (trials 13.0, literature 24.0, tier 5, approved bonus 0.0) |
| Registered trials | 5 total: 2 recruiting, 1 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 7 (2 Cochrane reviews, 2 systematic reviews, 2 clinical trial publications, 1 meta-analysis) |
| Agent type | Supplement (Herbal) |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Anxiety: a look at epidemiological factors and alternate treatments · Halma M, Covarrubias A, Selem E, Varon J · 2025 |
| Data sources | OSMF Chronic Disease Review |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01311180 | A Clinical Trial to Study the Effects of Sensoril® for Patients With Generalized Anxiety Disorder 2011 | completed | Phase 2 | 120 |
| NCT06235177 | Psychoneuromentalism Disorder: A Medical Condition That Affects People With Psychological Impairments From Health Issues 2024 | not yet recruiting | Early Phase 1 | 30 |
| NCT06714942 | Efficacy and Safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women With High Stress and Anxiety: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study 2024 | recruiting | Not applicable | 51 |
| NCT07441070 | Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress 2026 | recruiting | Not applicable | 80 |
| NCT05684991 | Prospective, Multi Centric, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) in Adults Experiencing High Stress and/or Anxiety 2022 | status unknown | Not applicable | 50 |
Published literature
- Clinical trial publication A standardized Ashwagandha root extract alleviates stress, anxiety, and improves quality of life in healthy adults by modulating stress hormones: Results from a randomized, double-blind, placebo-controlled studyMajeed M, Nagabhushanam K, Mundkur L · Medicine · 2023 · PMID 37832082
- Systematic review Interventions for generalized anxiety disorderByrne GJ · Current opinion in psychiatry · 2023 · PMID 36705012
- Meta-analysis Does Ashwagandha supplementation have a beneficial effect on the management of anxiety and stress? A systematic review and meta-analysis of randomized controlled trialsAkhgarjand C, Asoudeh F, Bagheri A et al. · Phytotherapy research : PTR · 2022 · PMID 36017529
- Cochrane review Medicinal Plants for Insomnia Related to Anxiety: An Updated ReviewBorrás S, Martínez-Solís I, Ríos JL · Planta medica · 2021 · PMID 34116572
- Cochrane review GABA-modulating phytomedicines for anxiety: A systematic review of preclinical and clinical evidenceSavage K, Firth J, Stough C et al. · Phytotherapy research : PTR · 2018 · PMID 29168225
- Clinical trial publication Evaluation of the efficacy of Withania somnifera (Ashwagandha) root extract in patients with obsessive-compulsive disorder: A randomized double-blind placebo-controlled trialJahanbakhsh SP, Manteghi AA, Emami SA et al. · Complementary therapies in medicine · 2016 · PMID 27515872
- Systematic review An alternative treatment for anxiety: a systematic review of human trial results reported for the Ayurvedic herb ashwagandha (Withania somnifera)Pratte MA, Nanavati KB, Young V et al. · Journal of alternative and complementary medicine (New York, N.Y.) · 2014 · PMID 25405876
Mechanism and notes
Recorded mechanism or class: Anxiety: a look at epidemiological factors and alternate treatments · Halma M, Covarrubias A, Selem E, Varon J · 2025.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Ashwagandha approved for Anxiety Disorders?
Ashwagandha has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Anxiety Disorders. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Ashwagandha in clinical trials for Anxiety Disorders?
ClinicalTrials.gov lists 5 registered trials linking Ashwagandha to Anxiety Disorders: 2 are currently recruiting; 1 is active or not yet recruiting; 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT01311180). It plans or enrolled 120 participants. Registration activity spans 2011 to 2026.
What does the evidence show for Ashwagandha in Anxiety Disorders?
Ashwagandha has both completed registered trials and synthesis-level publications linked to Anxiety Disorders. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.