KCT0002208招募中未知
A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors - Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial
Gil Korean Medicine Hospital, Gachon University0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 65(Year)（—）
- 性别
- Female
入选标准
- •Female aged 18 to 65 years
- •- Subject must included at least one or more of the following symptoms below
- •? Body Mass Index of 30 kg/? or more;
- •? Body Mass Index between 25 and 29.9kg/? with hypertension, taking medication or systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg at the screening visit
- •? Body Mass Index between 25 and 29.9kg/? with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose > 126mg/dL at the screening visit
- •? Body Mass Index between 25 and 29.9kg/? with hyperlipidemia, taking medication or total cholesterol = 200mg/dL or Triglyceride = 150mg/dL at screening visit
- •- Agreed to low-calorie diet during the trial
- •- Written informed consent of the trial
排除标准
- •- Endocrine diseases associated with weight gain, such as hypothyroidism, Cushing's syndrome, etc.
- •- Heart disease (heart failure, angina pectoris, myocardial infarction)
- •- Cholelithiasis
- •- Severe renal disability (serum creatinine concentration > 2.0 mg/dL)
- •- Severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase)
- •- History of narrow angle glaucoma
- •- History of stroke or temporary ischemic cardioplegia
- •- History of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
- •- Use of medication that can affect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medications can affect on absorption, metabolism, excretion)
- •- Use of central nerve system(CNS) stimulant medication for weight loss
- •- Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
- •- history of weight loss surgery, such as bariatric surgery, etc.
- •- Subjects who are judged to be inappropriate for the clinical study by the researchers
- •- Women who were pregnant, lactating or have the chances of pregnancy who do not agree to proper contraception (birth-control pill, hormone implant, intrauterine device, spermicide, condom, abstinence, etc.)
- •- Use of other investigational product within last 1 month
- •- 10 percent reduction in body weight over 6 months
- •- Decided to quit smoking over the last 3 months or have irregular smoking habits
研究者
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