NCT07215455Completed
Ashwagandha Extract for Weight and Stress Management in Overweight and Obese Adults
Efficacy And Safety of KSM66 Ashwagandha (Withania Somnifera) Standardized Root Extract (300 mg) on Weight and Stress Management in Overweight and Obese Adults: A Prospective, Randomized, Double-Blind Placebo- Controlled Study
Source: ClinicalTrials.gov · Last updated 6 Nov 2025
Brief summary (registry, in English)
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 somnifera) is a traditional herbal supplement that may help reduce stress and support overall health. In this randomized, double-blind, placebo-controlled trial, participants will receive either Ashwagandha extract or a placebo for the study duration. The main goal is to measure changes in body weight and stress levels. Other health outcomes, such as body mass index (BMI), waist circumference, and quality of life, will also be assessed. The study will help determine whether Ashwagandha is effective and safe for managing stress and supporting weight loss in adults with overweight or obesity.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 2 Oct 2025
- Start date
- 17 Jun 2025
- Primary completion date
- 22 Oct 2025
- Lead sponsor
- SF Research Institute, Inc.
- Diseases
- Obesity
- NCT number
- NCT07215455
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 17 Jun 2025 to the primary completion date, 22 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking nutritional or energy supplements, medication, or steroids,
- Participation in other clinical trials during previous 3 months
Other illness
- History of Alcohol or smoking abuse.
- History of hypersensitivity to Ashwagandha
- Any history of drug abuse
- 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.
- Any clinical condition, according to the investigator which does not allow safe fulfilment of clinical trial protocol.
Other
- Having any clinical abnormalities
- Simultaneously participating in any other clinical trial or participated in the past three months
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Francisco Research Institute Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.