Multi-center Randomized Controled and Double Blind Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- Hemoglobin A1c (HbA1c)
研究概览
简要总结
Tang-min-ling pills are made by Chinese herbs extract, and data showed they had antidiabetic effects on the experimental rats and no obvious toxicity was found.This is a randomized, doubled blind, dose-paralleled-control multi-centre clinical trial to evaluate the efficacy and safety of Tang-min-ling pills in the treatment of type 2 diabetic patients and explore the optimal dosage of Tang-min-ling pills.
详细描述
Two hundred and ten of overweight patients inflicted with primary diabetes mellitus who had stagnated heat of liver and stomach syndrome were recruited, which were randomly divided into 3 groups, and were given high-dosage (12g Tang-min-ling pills every time), low-dosage (6g Tang-min-ling pills every time)、placebo by 3 times every day for 12 weeks respectively. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary type 2 diabetes mellitus
- •BMI ≥ 24 kg•m-2
- •30-70 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
- •stagnated heat of liver and stomach syndrome according to TCM syndrome differentiation
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 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 couldn't 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
placebo
Tang-min Lin pills analogue
干预措施: Placebo (Drug)
Tang-min-ling pills high dosage
Tang-min-ling pills, high dosage, 12g, tid po
干预措施: Tang-min-ling pills high dosage (Drug)
Tang-min-ling pills low dosage
low dosage group:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
干预措施: Tang-min-ling pills low dosage (Drug)
结局指标
主要结局
Hemoglobin A1c (HbA1c)
时间窗: 12 weeks after treatment
The HbA1c was measured and analyzed twice, one is before the treatment and the other is 12 weeks aftertreatment to make a self comparison.
次要结局
- Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、body mass index (BMI)、waist circumference (WC)(12 weeks after treatment)
- The rate of adverse events,the blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests(12 weeks after treatment)
- symptoms score and Chinese syndrome(12 weeks after treatment)