NCT07215455

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: SF Research Institute, Inc. · Network
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Weight Management
• Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ashwagandha 300 mg standardized root extract	Participants in this group will receive KSM-66 Ashwagandha, a standardized root extract of Withania somnifera, 300 mg once daily in capsule form. KSM-66 is a high-concentration, full-spectrum extract of Ashwagandha root, designed to provide adaptogenic effects for stress reduction and support weight management. Participants will be instructed to take the capsule with water, preferably at the same time each day, for the duration of the 8-week study. Adherence will be monitored via pill counts and participant diaries.
OTHER	Identical placebo capsule.	Participants in this group will receive an identical placebo capsule that matches the appearance, size, color, and taste of the KSM-66 Ashwagandha capsule but contains inactive ingredients. The placebo is administered once daily for 8 weeks. Participants will be instructed to take the capsule with water, preferably at the same time each day. Adherence will be monitored via pill counts and participant diaries. The use of a placebo allows comparison with the Ashwagandha group to evaluate efficacy and safety outcomes while maintaining blinding for participants and study staff.

Timeline

• Start date: 2025-06-17
• Primary completion: 2025-10-22
• Completion: 2025-10-22
• First posted: 2025-10-10
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States