Status:
COMPLETED
Ashwagandha Extract for Weight and Stress Management in Overweight and Obese Adults
Lead Sponsor:
SF Research Institute, Inc.
Conditions:
Weight Management
Stress
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
This study is designed to evaluate the effects of KSM-66 Ashwagandha root extract (300 mg daily) on weight management and stress reduction in overweight and obese adults. Ashwagandha (Withania somnife...
Detailed Description
This randomized, double-blind, placebo-controlled clinical study is being conducted to investigate the potential efficacy and safety of KSM-66 Ashwagandha® root extract (300 mg per capsule) in promoti...
Eligibility Criteria
Inclusion
- Healthy adult men and women participants ≥ 19 years and ≤65 years of age.
- Willingness to follow the protocol requirements as evidenced by written informed consent.
- Participants willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
- Participants who agree to take investigational product (i.e., Till Week 8).
- Participants with Body mass index between 25 and 39.9 kg/m2
Exclusion
- History of Alcohol or smoking abuse.
- History of hypersensitivity to Ashwagandha
- Taking nutritional or energy supplements, medication, or steroids,
- Any history of drug abuse
- Having any clinical abnormalities
- Simultaneously participating in any other clinical trial or participated in the past three months
- Participants who use medication for blood pressure, use beta-blockers, inhaled any beta-agonists, use any hormonal contraceptives, having a history of corticosteroid use within three months, participants under psychotropic medication within last 8 weeks
- Participants diagnosed with any heart disease, diabetes, stroke, neurological disorders or depression.
- Have clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
- Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania.
- Patients with post traumatic disorder.
- Have an established practice of meditation (as meditating for at least 20 minutes, three or more times per week) for three or more months.
- Pregnant and lactating women
- Participation in other clinical trials during previous 3 months
- Any clinical condition, according to the investigator which does not allow safe fulfilment of clinical trial protocol.
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07215455
Start Date
June 17 2025
End Date
October 22 2025
Last Update
November 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
San Francisco Research Institute
San Francisco, California, United States, 94132