NCT06244147Completed
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 · Last updated 6 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 24 Jan 2024
- Start date
- 15 Feb 2024
- Primary completion date
- 15 Oct 2025
- Lead sponsor
- SF Research Institute, Inc.
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT06244147
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 15 Feb 2024 to the primary completion date, 15 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 who had participated in other clinical trials during previous 3 months.
Other illness
- 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 have any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SF Research Institute Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.