NCT01142076已完成不适用
Xinju Xiaogao Prescription and 10% of it in the Treatment of Adiposity (Stagnation of QI Causing Phlegm Retention)Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- waistline
研究概览
简要总结
Xinju Xiaogao prescription and 10% of it in the treatment of adiposity (stagnation of QI causing phlegm retention)clinical study
详细描述
Charged by the three research centers in line with traditional Chinese medicine stagnation of QI causing phlegm retention 120 cases have diabetes were randomly divided into Chinese herbal compound Xinju Xiaogao prescription group and 10% of the prescription group.The treatment groups were compared 24-week step-down and regulation of body weight,waistline, blood lipids, blood sugar effect.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-60 years old
- •BMI≥28kg/m2，but<40kg/m2
- •Waistline≥85cm（male）,≥80cm（female）
- •Pathoglycemia must fulfill one of those four condition:
- •IGT,7.8≤2hPG≤11.0mmol/,
- •diabetics take medicine used to treat type 2 diabetes more than 3 month,and 5.6≤FBG≤12.2,and weight change under 4kg.
- •stagnation of QI causing phlegm retention
- •To sign informed consent.
排除标准
- •After 3-6 months simply controlling their diet and more exercise treatment, body weight weight loss ≥ 5%.
- •TG>4.5mmol/L.
- •Suffering from congenital heart disease, rheumatic heart disease, kidney disease, serious active liver disease, peptic ulcer disease or malabsorption syndrome.
- •There is a history of pancreatitis or endocrine diseases other than diabetes, diabetes treated with insulin.
- •Not suffered myocardial infarction in Past 3 months or unstable angina were confirmed.
- •Had been diagnosed as "post-surgical adhesions" .
- •There is a history of appetite or abuse of laxatives
- •Diastolic blood pressure,uncontrolled or controlled, three times greater than 105mmHg .
- •Pregnancy, prepare to pregnant or lactating women prepare.
- •Allergies to Chinese medicine , allergic.
- •Recurrent gallstone or a history of kidney stones.
- •Mentally ill.
- •Cancer patients.
- •A history of gastrointestinal surgery to lose weight.
- •Receiving other clinical studies nearly 3 months.
- •Alcohol and / or psychoactive substances, drug abusers and addicts.
- •Taking other weight-reducing aid Close within one month
研究组 & 干预措施
placebo
Placebo Comparator
Dose treatment group, 10%
干预措施: placebo (Drug)
Xinju Xiaogao Prescription
Active Comparator
treatment group
干预措施: Xinju Xiaogao Prescription (Drug)
结局指标
主要结局
waistline
时间窗: up to 24 weeks
次要结局
- Body Mass Index (BMI)(up to 24 weeks)
研究者
Fengmei Lian
chief
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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