ISRCTN37381706已完成不适用
Efficacy of three nutraceutical products of herbal origin in weight management of obese human subjects: a randomised, double blind, placebo controlled clinical study
aila Nutraceuticals (India)0 个研究点目标入组 100 人开始时间: 2007年11月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults aged 21 - 50 years
- •2. Body Mass Index (BMI) greater than or equal to 30 kg/m^2
- •3. Willingness to participate in an exercise-walking program, supervised by a trained exercise specialist
- •4. Willingness to consume the prescribed study diet of approximately 2,000 KCal per day as outlined in the protocol (meals will be provided at free of cost by the study sponsor)
- •5. Written informed consent to participate in the trial
- •6. Willingness to complete standard health history questionnaire before induction into the study
- •7. Willingness to participate in five clinic visits (screening, baseline, 2, 4 & 8 weeks)
- •8. If female:
- •8.1. Should be negative in pregnancy test
- •8.2. If of childbearing potential, should agree to follow an acceptable method of birth control for the duration of the study, such as condoms, foams, jellies, diaphragm, Intrauterine Device (IUD), etc.
- •8.3. Postmenopausal for at least 1 year
- •8.4. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
排除标准
- •1. History of thyroid disease or cardiovascular disease or diabetes
- •2. Any other clinically significant disorder
- •3. History of allergy to spices and herbal products
- •4. Intractable obesity or uncontrolled body weight, BMI greater than 40 kg/m^2
- •5. Presently using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss
- •6. Recent, unexplained weight loss or gain
- •7. Positive Human Immunodeficiency Virus (HIV) test
- •8. History of hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis
- •9. History of motor weakness or peripheral sensory neuropathy
- •10. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
研究者
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