Evaluating the long-term safety and effectiveness of KSM-66 Ashwagandha in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• SF Research Institute
  San Francisco, California, United States Recruiting

Study contacts

• Study coordinator: John Ademola, PhD
• Email: studyrecruitment@sfinstitute.com
• Phone: 415-549-9362

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.