Long Term Safety and Efficacy of KSM-66 Ashwagandha in Adults

Completed

Conditions studied: All

In brief

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.

Key facts

Study ID

NCT06244147

Run by

SF Research Institute, Inc.

People needed

200

Starts

2024-02-15

Expected to finish

2025-10-15

Last updated by the study team

2025-11-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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