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

Launched by SF RESEARCH INSTITUTE, INC. · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a product called KSM-66 Ashwagandha, which is a natural supplement made from the Ashwagandha plant. The researchers want to find out if this supplement is safe to take over a period of 12 months and how well it works for various conditions. They are currently looking for adults aged 18 to 65 who have been prescribed KSM-66 Ashwagandha by their doctor for long-term use. Participants should be willing to sign a consent form and should have a body mass index (BMI) between 25 and 39.9, meaning they are classified as overweight or mildly obese.

If eligible, participants can expect to be monitored throughout the year for any side effects and to see how the supplement affects their health. It's important to note that some people may not qualify to participate, including those who recently took medications for stress or anxiety, have certain mental health conditions, or have significant health issues that could interfere with the study. By participating, individuals will help researchers better understand the benefits and safety of KSM-66 Ashwagandha for future patients.

Gender

ALL

Eligibility 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.