Dosage-efficacy Relationship Clinical Trial of Ge Gen Qin Lian Decoction
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- HbA1c
研究概览
简要总结
Ge Gen Qin Lian Decoction are one kind of Chinese prescription, and previous study showed they had antidiabetic effects on the clinical patients and no obvious toxicity was found. The purpose of this study was to evaluate the efficacy and safety of different dosage of Ge Gen Qin Lian Decoction in the treatment of type 2 diabetic patients and explore relationship of the dosage and effect and the safety of 3 dosages of Ge Gen Qin Lian Decoction.
详细描述
two hundred and forty primary diabetic patients will be expected to be recruited, which were divided into different groups in a randomized, doubled blind, dose-paralleled-control multi-centre clinical design. The patients were randomly taken with high-dosage(5 times of low-dosage),mild-dosage(3 times of low-dosage), low-dosage,placebo(4.5% of low dosage) by 2 times every day for 12 weeks. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG),postprandial 2 hours plasma glucose(2hPG),insulin(0h,1h,2h),syndrome,symptoms,body mass index (BMI),waist circumference (WC) of these groups were measured and analyzed. Some safety indexes such blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and analyzed during the experiment. The treatment period is 12 week.
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
- Double (Participant, Care Provider)
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
- •Clinical diagnosis of type 2 diabetes mellitus
- •30-65 years old
- •HbA1c≥7.0%, and FPG>7.0 mmol/L, but <13.9 mmol/L or 2hPG>11.1 mmol/L
- •Informed consent has been signed
- •Dampness and Heat in Spleen
排除标准
- •The patients accepted diabetic treatment for more than a month continuously
- •The patients were treated by drugs in 3 week before they were given test drugs
- •Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month
- •The contractive pressure >160 mmHg or diastolic pressure >100 mmHg
- •Pregnant, preparing for pregnancy or breast-feeding women
- •Mental patients
- •The patients whose ALT or AST are >100U/L,and BUN or Cr are abnormal.
- •The patients who have serious heart, lung, liver, kidney and brain or other primary complications
- •Allergic persons
- •The patients who are attending other clinical trial
- •The patients who have serious diabetic complications
- •The patients who ever attended this clinical trial
- •Alcohol and / or psychoactive substances, drug abuse and dependency
- •The person maybe loss for some reason such as work or life condition according to the investigator's judgement
- •The lipid-lowering or antihypertensive drug dosage and category which the patients are taking could not be kept stable
- •The patients who are eating some drugs or health food which can affect the body weight
研究组 & 干预措施
High dose GGQL Decoction
干预措施: High Dose GGQL Decoction (Drug)
Mild dose GGQL Decoction
干预措施: Mild dose GGQL Decoction (Drug)
Low dose GGQL Decoction
干预措施: Low dose GGQL Decoction (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c
时间窗: 12 weeks after treatment
次要结局
- Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)(12 weeks after treatment)
- blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests(12 weeks after treatment)
- Ins(0h,1h,2h),blood lipids(12 weeks after treatment)
研究者
Tong Xiaolin
Professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences