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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mean change in body weight and BMI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Mean change in body weight and BMI
时间窗: aseline (Visit 1/Screening/Enrolment), Week 4 (Visit 2), Week 12 (Visit 3/End of Study)
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.
次要结局
- Mean change in Perceived Stress Scale (PSS-10) score(Baseline, Week 4, Week 12)
- Mean change in SF-12 Health Survey score(Baseline, Week 4, Week 12)
- Mean change in SSS (Stress Symptom Scale) score(Baseline, Week 4, Week 12)
- Mean change in Food Cravings Questionnaire-Trait (FCQ-T) score(Baseline, Week 4, Week 12)
- Mean change in Complete Blood Count (CBC)(Baseline, Week 4, Week 12)
- Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(12-week treatment period)
- Mean change in Lipid Profile(Baseline, Week 4, Week 12)
- Mean change in Liver Function Test (LFT)(Baseline, Week 4, Week 12)
- Mean change in Renal Function Test (RFT)(Baseline, Week 4, Week 12)
- Mean change in Thyroid Function Parameters(Baseline, Week 4, Week 12)
- Mean change in Fasting Blood Sugar (FBS)(Baseline, Week 4, Week 12)
- Mean change in Glycated Hemoglobin (HbA1c)(Baseline, Week 4, Week 12)