An interventional study of Ashwagandha 300 mg standardized root extract and Identical placebo capsule. in Weight Management and Stress, sponsored by SF Research Institute, Inc.. Completed at 1 site in United States. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-06.
Sponsored by SF Research Institute, Inc. · Not applicable, Interventional, and Treatment
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.
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.
SF Research Institute, Inc. is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ashwagandha 300 mg root extract in a dose of 300 mg capsules orally twice daily after breakfast and dinner with a glass of water or milk for 12 weeks.
Dietary Supplement: Ashwagandha 300 mg standardized root extract
Identical Placebo in a dose of 300 mg capsules orally twice daily after breakfast and dinner with a glass of water or milk for 12 weeks.
Other: Identical placebo capsule.
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.
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.
Mean change in body weight and BMI
Change from baseline in body weight (kg) and body mass index (BMI, kg/m²) will be assessed in overweight and obese adult participants at Week 4 and Week 12. Measurements will be performed using standardized calibrated equipment under consistent conditions at each visit.
Time frame: aseline (Visit 1/Screening/Enrolment), Week 4 (Visit 2), Week 12 (Visit 3/End of Study)
Mean change in Perceived Stress Scale (PSS-10) score
Change from baseline in PSS-10 scores, measuring perceived stress levels in overweight and obese adult participants, at Week 4 and Week 12.
Time frame: Baseline, Week 4, Week 12
Mean change in SF-12 Health Survey score
Change from baseline in SF-12 scores, evaluating physical and mental health-related quality of life in overweight and obese adult participants, at Week 4 and Week 12.
Time frame: Baseline, Week 4, Week 12
Mean change in SSS (Stress Symptom Scale) score
Change from baseline in SSS scores, assessing self-reported stress symptoms in overweight and obese adult participants, at Week 4 and Week 12.
Time frame: Baseline, Week 4, Week 12
Mean change in Food Cravings Questionnaire-Trait (FCQ-T) score
Change from baseline in FCQ-T scores, evaluating trait-level food cravings in overweight and obese adult participants, at Week 4 and Week 12.
Time frame: Baseline, Week 4, Week 12
Mean change in Complete Blood Count (CBC)
Change from baseline in hematological parameters including hemoglobin (g/dL), total leukocyte count (cells/µL), and platelet count (cells/µL) measured by automated hematology analyzer.
Time frame: Baseline, Week 4, Week 12
Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
All TEAEs and TESAEs occurring during the 12-week intervention period will be recorded and summarized by number and proportion of participants affected, severity, and relationship to study intervention.
Time frame: 12-week treatment period
Mean change in Lipid Profile
Change from baseline in serum lipid parameters including total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), and triglycerides (mg/dL) measured by enzymatic colorimetric method.
Time frame: Baseline, Week 4, Week 12
Mean change in Liver Function Test (LFT)
Change from baseline in liver function parameters including serum alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), alkaline phosphatase (ALP; U/L), and total bilirubin (mg/dL) measured using automated biochemistry analyzer.
Time frame: Baseline, Week 4, Week 12
Mean change in Renal Function Test (RFT)
Change from baseline in renal function parameters including serum creatinine (mg/dL) and blood urea nitrogen (BUN; mg/dL) measured using automated biochemistry analyzer.
Time frame: Baseline, Week 4, Week 12
Mean change in Thyroid Function Parameters
Change from baseline in serum Thyroxine (T4; µg/dL), Triiodothyronine (T3; ng/dL), and Thyroid-Stimulating Hormone (TSH; µIU/mL) measured by chemiluminescent immunoassay.
Time frame: Baseline, Week 4, Week 12
Mean change in Fasting Blood Sugar (FBS)
Change from baseline in fasting blood glucose level (mg/dL) measured by enzymatic glucose oxidase method.
Time frame: Baseline, Week 4, Week 12
Mean change in Glycated Hemoglobin (HbA1c)
Change from baseline in HbA1c (%) measured by high-performance liquid chromatography (HPLC).
Time frame: Baseline, Week 4, Week 12
Plan to share: No
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SF Research Institute, Inc.