Evaluating the long-term safety and effectiveness 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
This study is testing whether KSM-66 Ashwagandha is safe and effective for adults over a year to help them understand its long-term effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | SF Research Institute, Inc. Research network |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06244147 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term safety and efficacy of KSM-66 Ashwagandha, a root extract, administered to adults over a period of 12 months. Participants aged 18 to 65 who have been prescribed this supplement will be monitored for any adverse effects and overall effectiveness. The study will include a total of 200 subjects across multiple sites, with participants required to comply with study procedures and provide informed consent. Data will be collected through medical history, clinical examinations, and regular follow-ups during the study period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been prescribed KSM-66 Ashwagandha for long-term use and have a BMI between 25 and 39.9 kg/m2.
Not a fit: Patients currently taking medications that affect stress and anxiety or those with certain mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term benefits and safety of KSM-66 Ashwagandha for various health conditions.
How similar studies have performed: While there is limited data on the long-term effects of KSM-66 Ashwagandha, similar herbal interventions have shown promise in other studies, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California
- SF Research Institute — San Francisco, California, United States (Recruiting)
Study contacts
- Study coordinator: John Ademola, PhD
- Email: studyrecruitment@sfinstitute.com
- Phone: 415-549-9362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.