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NCT06244147
Long Term Safety and Efficacy of KSM-66 Ashwagandha in Adults
trial testing KSM-66 Ashwagandha Root Extract in All in 200 participants. Completed in 15 October 2025.
15 October 2025
Quick facts
| Lead sponsor | SF Research Institute, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 15 February 2024 |
| Primary completion | 15 October 2025 |
| Estimated completion | 15 October 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- KSM-66 Ashwagandha Root Extract
Conditions studied
- All — all drugs for All →
Sponsor
SF Research Institute, Inc.
Who can join
Adults 18 to 65, any sex, with All. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective is to evaluate the clinical safety of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months. The secondary objectives are to evaluate the laboratory safety of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months and to evaluate the efficacy of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety of 12-Months Administration of Ashwagandha (Withania somnifera) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study.
Salve J, Kale S, Prajapati BL, Sparavigna A, et al · · 2025 · cited 2× · PMID 41063394 · DOI 10.1002/ptr.70096
Verify or expand the search:
- PubMed search for NCT06244147
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other SF Research Institute, Inc. trials
Trials by the same sponsor.
- NCT07441070 — Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress · NA · enrolling by invitation
- NCT07441096 — Efficacy and Safety of Shatavari Root Extract for Premenstrual Syndrome in Women · NA · not yet recruiting
- NCT07441083 — Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness · NA · not yet recruiting
- NCT07441109 — Shatavari Root Extract for Perimenopausal Symptoms · NA · not yet recruiting
- NCT07421596 — An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06244147 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SF Research Institute, Inc.
- Last refreshed: 6 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06244147.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing