NCT01471275Unknown不适用
The Study of TCM in Prevention and Promote of Community-based Diabetes
Guang'anmen Hospital of China Academy of Chinese Medical Sciences8 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 8
- 主要终点
- Glycosylated hemoglobin
研究概览
简要总结
With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi decoction in treatment of obesity with type 2 diabetes, dyslipidemia
详细描述
Waist circumference, body mass index, triglycerides, glycosylated hemoglobin, blood glucose were evaluated; liver function, kidney function, blood, urine, stool, adverse event recording, evaluation of low blood sugar event log security.
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
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent;
- •waistline male ≥ 90cm, female ≥ 80cm;
- •According to the 1999 WHO standards, meet diagnostic criteria for type 2 diabetes onset and untreated patients, after a screening period (diet + exercise therapy 4 weeks) after the fasting plasma glucose ≥ 7.0mmol • L-1, but fasting blood glucose <13.9mmol • L-1, or 2h postprandial blood glucose ≥ 11.1mmol • L-1; and glycated hemoglobin ≥ 7.0%;
- •After a screening period (diet + exercise therapy 4 weeks) after the triglyceride (TG) ≥ 1.7mmol / L, and TG <5.65mmol / L;
- •TCM for the heat of the gastrointestinal;
- •Age 30-65 years old.
排除标准
- •Patients has been used insulin therapy; previously had a continuous period of 3 months or longer treatment of diabetes(including other Chinese and Western medicine, physical therapy, psychological therapy and health food, etc.) ; enrolled within 1 month before the use of blood glucose and lipids drug treatment;
- •Patients with diabetic complications; or a serious heart, lung, liver, kidney, brain and other serious complications or associated with other primary diseases;
- •Patients with uncontrolled blood pressure control, the systolic blood pressure ≥ 160mmHg or (and) diastolic blood pressure ≥ 100mmHg persons;
- •Patients have diabetic ketoacidosis in the last month, diabetic ketoacidosis and severe infections;
- •Patients with mental illness;
- •Pregnancy, pregnancy or breast-feeding women to prepare;
- •Patients with Chinese medicine allergies; and allergy;
- •Patients with had participated in this study within 1 month have participated or are participating in other clinical studies;
- •In the past five years, patients with alcohol and / or psychoactive substances, drug abuse and dependence;
- •According to the researchers to determine, with the possibility of lower income group or the other into a complex set of diseases or conditions, such as work environment, frequent changes in unstable living environment, the situation could easily lead to lost;
- •Patients taking the dose and type of antihypertensive drugs can not remain stable;
- •Patients taking drugs that affect the quality of the body or health food.
- •Patients with liver, impaired renal function (ALT, AST greater than 2 times the upper limit of normal; serum creatinine greater than the upper limit of normal);
- •Patients are known to lower blood sugar for those who are asymptomatic.
研究组 & 干预措施
Jiangtangtiaozhi decoction
Experimental
干预措施: Jiangtangtiaozhi decoction (Drug)
metformin
Active Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
Glycosylated hemoglobin
时间窗: 12 weeks
次要结局
- Whole blood cell analysis(4 weeks)
- Urinalysis(12 weeks)
- Adverse events recorded(4 weeks)
- Liver function(4 weeks)
- Renal function(4 weeks)
- Waistline(4 weeks)
- Triglycerides(12 weeks)
研究者
Fengmei Lian
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (8)
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