NCT01082835Unknown不适用
Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat), Randomized, Parallel-controlled, Multi-center Clinical Study
Guang'anmen Hospital of China Academy of Chinese Medical Sciences5 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2010年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 5
研究概览
简要总结
Jangzhuo Qinggan prescription and irbesartan in the treatment of essential hypertension(Hepatogastric Damp-heat), randomized, parallel-controlled, multi-center clinical study.
详细描述
Charged by the five research centers in line with traditional Chinese medicine hepatogastric Damp-heat syndrome 240 cases have hypertension, and overweight, as well as blood lipid disorders or diabetes were randomly divided into Chinese herbal compound Jiangzhuo Qinggan prescription group and western medicine irbesartan group.The treatment groups were compared 4-week step-down and regulation of blood lipids, blood sugar effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consistent with diagnosed hypertension, blood pressure, for 1-2 grade.
- •Aged 18-65 years old.
- •Body mass index (BMI) ≥ 24kg/m2, but <35 kg/m
- •Waist circumference ≥ 85cm (male) or waist circumference ≥ 80cm (women).
- •Comply with any of the following 3 : triglyceride (TG) elevated levels of:> 150mg/dl (1.7mmol / l), or has received appropriate treatment; high-density lipoprotein - cholesterol (HDL-C) levels reduced: Men <40mg/dl (0.9mmol / l), women <50mg/dl (1.1mmol / l), or has received appropriate treatment; fasting plasma glucose (FPG) increased: FPG ≥ 100mg/dl (5.6mmol / l ), or previously diagnosed type 2 diabetes or have received appropriate treatment.
- •Hepatogastric Damp-heat syndrome differentiation.
- •To sign informed consent.
排除标准
- •Has been used to control lipids, blood sugar drugs, but use the time for those below the 1 month.
- •Nearly 3 months, weight loss ≥ 5%.
- •Suffering from congenital heart disease, rheumatic heart disease, congestive heart failure, unstable angina, and had a myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or off-line clinical significance of arrhythmia.
- •Bilateral renal artery stenosis, solitary kidney, serum creatinine> 133μmol / L .
- •Active liver disease, history of chronic persistent hepatitis, ALT> upper limit of normal.
- •Peptic ulcer or malabsorption syndrome .
- •With insulin-treated diabetes.
- •There is a history of appetite or abuse of laxatives by hyperthyroidism.
- •Pregnancy, pregnancy or breast-feeding women to prepare.
- •For those who are allergic Chinese medicine, allergic people.
- •Mentally ill.
- •Hyperkalemia in patients.
- •Occurred within the past 6 months who had a stroke or transient ischemic attack (TIA).
- •Nearly 3 months in patients receiving other clinical studies.
- •Alcohol and / or psychoactive substances, drug abuse and dependency.
研究者
研究点 (5)
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