Clinical trial · Observational
Long Term Safety and Efficacy of KSM-66 Ashwagandha in Adults
Long Term Safety and Efficacy of KSM-66 Ashwagandha (Standardized Root Extract of Withania Somnifera) in Adults: A Prospective, Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| All | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KSM-66 Ashwagandha Root Extract | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
- 12 months
- description
- Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) due to KSM-66 Ashwagandha (Withania Somnifera) over 12 months period
Secondary outcomes (12)
- measure
- Liver Parameters
- timeFrame
- 6 and 12 months
- description
- Changes in laboratory values for serum alanine transaminase 6 months and 12 months after start of KSM-66 Ashwagandha
- measure
- Liver Parameters
- timeFrame
- 6 and 12 months
- description
- Changes in laboratory values for aspartate transaminase 6 months and 12 months after start of KSM-66 Ashwagandha
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Adults (male and female) aged between 18 and 65 years. * Prescribed KSM-66 Ashwagandha by their clinicians for long-term period. * No plan to commence any other alternative treatment modality for their conditions. * Willingness to sign an informed consent document and to comply with all study related procedures. * Participants with Body mass index between 25 and 39.9 kg/m2. Exclusion Criteria: * Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening. * Patients currently (or within the past 4 weeks prior to screening) taking any over the counter use of herbal extracts such as Ginkgo Biloba, St. John's Wort, Omega-3 etc. * Patients with depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania. * Patients with known post-traumatic stress disorder (PTSD). * Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study. * Patients with known hypersensitivity to Ashwagandha. * Patients who had participated in other clinical trials during previous 3 months. * Patients who have any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol.
References
Publications (1)
- DERIVEDSalve J, Kale S, Prajapati BL, Sparavigna A, Savant M, Ademola J, Langade D. Safety of 12-Months Administration of Ashwagandha ( Withania somnifera ) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study. Phytother Res. 2026 Aug;40(8):4802-4812. doi: 10.1002/ptr.70096. Epub 2025 Oct 8. PMID 41063394