NCT02651454已完成4 期
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 -
Gachon University Gil Oriental Medical Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年12月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes from baseline in body weight
研究概览
简要总结
The Purpose of this trial is to investigate the efficacy and safety of Daesiho-tang and Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18 to 65 years
- •Subject must included at least one or more of the following symptoms below
- •BMI of 30 kg/㎡ or more;
- •BMI between 25 and 29.9kg/㎡ with hypertension, taking medication or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit
- •BMI between 25 and 29.9kg/㎡ with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose > 126mg/dL at the screening visit
- •BMI 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 (SCr > 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 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, IUD, 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
研究组 & 干预措施
Daesiho-tang
Experimental
Dose: 6g, three times a day, each taken before or between meals for 12 weeks
干预措施: Daesiho-tang (Drug)
Jowiseungcheung-tang
Experimental
Dose: 6g, three times a day, each taken before or between meals for 12 weeks
干预措施: Chowiseungcheng-tang (Drug)
Placebo
Placebo Comparator
Dose: 6g, three times a day, each taken before or between meals for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in body weight
时间窗: baseline, 12 weeks
次要结局
- Changes from baseline in Body mass index(baseline, 4,8,12,16 weeks)
- Changes from baseline in C-reactive protein (CRP)(Screening visit, 12 weeks)
- Changes from baseline in abdominal visceral fat area(baseline, 12 weeks)
- Korean version of Eating Attitudes Test-26(baseline, 12 weeks)
- Changes from baseline in fat mass(baseline, 4,8,12,16 weeks)
- Changes from baseline in Waist/hip ratio(baseline, 4,8,12,16 weeks)
- Changes from baseline in body fat percentage(baseline, 4,8,12,16 weeks)
- Changes from baseline in Waist circumference(baseline, 4,8,12,16 weeks)
- Changes from baseline in Lipid profile(Screening visit, 12 weeks)
- Korean Obesity-related Quality of Life (QoL) scale(baseline, 12 weeks)
- Changes from baseline in blood glucose(Screening visit, 12 weeks)
研究者
Yun-Kyung Song
KMD, PhD
Gachon University Gil Oriental Medical Hospital
研究点 (1)
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