Ashwagandha Extract for Weight and Stress Management in Overweight and Obese Adults

Last updated: November 5, 2025
Sponsor: SF Research Institute, Inc.
Overall Status: Completed

Phase

N/A

Condition

Stress

Weight Loss

Treatment

Identical placebo capsule.

Ashwagandha 300 mg standardized root extract

Clinical Study ID

NCT07215455
Ixoreal-Weight-CT-03-23
  • Ages 19-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy adult men and women participants ≥ 19 years and ≤65 years of age.

  2. Willingness to follow the protocol requirements as evidenced by written informedconsent.

  3. Participants willing to give meaningful, written informed consent prior toparticipation in the trial, in accordance with regulatory requirements.

  4. Participants who agree to take investigational product (i.e., Till Week 8).

  5. Participants with Body mass index between 25 and 39.9 kg/m2

Exclusion

Exclusion Criteria:

  1. History of Alcohol or smoking abuse.

  2. History of hypersensitivity to Ashwagandha

  3. Taking nutritional or energy supplements, medication, or steroids,

  4. Any history of drug abuse

  5. Having any clinical abnormalities

  6. Simultaneously participating in any other clinical trial or participated in the pastthree months

  7. Participants who use medication for blood pressure, use beta-blockers, inhaled anybeta-agonists, use any hormonal contraceptives, having a history of corticosteroiduse within three months, participants under psychotropic medication within last 8weeks

  8. Participants diagnosed with any heart disease, diabetes, stroke, neurologicaldisorders or depression.

  9. Have clinically significant acute unstable hepatic, renal, cardiovascular, orrespiratory disease that will prevent participation in the study.

  10. Patients with depressive episode, panic disorder, social phobia,obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania.

  11. Patients with post traumatic disorder.

  12. Have an established practice of meditation (as meditating for at least 20 minutes,three or more times per week) for three or more months.

  13. Pregnant and lactating women

  14. Participation in other clinical trials during previous 3 months

  15. Any clinical condition, according to the investigator which does not allow safefulfilment of clinical trial protocol.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Identical placebo capsule.
Phase:
Study Start date:
June 17, 2025
Estimated Completion Date:
October 22, 2025

Study 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 promoting weight management and reducing stress in adults classified as overweight or obese.

Participants will be randomly assigned to receive either KSM-66 Ashwagandha® capsules or matching placebo capsules for the study duration. Each participant will undergo baseline and follow-up assessments that include anthropometric measurements (body weight, BMI, and waist circumference), psychological evaluations (Perceived Stress Scale and related questionnaires), and laboratory investigations relevant to metabolic and stress-related health.

The study hypothesis is that daily supplementation with KSM-66 Ashwagandha® will lead to a statistically significant reduction in stress levels and body weight compared to placebo. The trial outcomes are expected to contribute to the growing body of evidence supporting the role of Ashwagandha as a safe and natural adaptogenic supplement for weight and stress management in adults.

Connect with a study center

  • San Francisco Research Institute

    San Francisco 5391959, California 5332921 94132
    United States

    Site Not Available

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