NCT01087242Unknown3 期
Randomized，Double-blind，Dose Parallel Controlled, Multicentre Clinical Trail of Tang-min-Ling Pills and Placebo in Diabetes Mellitus(Liver-stomach Heat Retention Syndrome) (Phase Ⅲ)
Guang'anmen Hospital of China Academy of Chinese Medical Sciences4 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 480
- 试验地点
- 4
- 主要终点
- glycosylated hemoglobin
研究概览
简要总结
This is a randomized, doubled blind, dose-paralleled control, multi-centre clinical trail,to evaluate the efficacy of Tang-min-ling pills in the treatment of type 2 diabetes mellitus.
详细描述
Type 2 diabetes mellitus combined liver-stomach heat retension syndrome were recruited, which were divided into 3 groups .The patients were randomly taken with 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.
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, Investigator)
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
- •initial treatment type 2 diabetic patient
- •liver-stomach heat retention syndrome
- •BMI ≥24kg/m2
- •aged 30-65 years
- •after screening stage(lifestyle intervention),Hba1C≥7.0%,FPG7.0-13.3mmol/L or PG2h>11.1mmol/L;
- •voluntary signs the informed consent
排除标准
- •have used anti-diabetes drug before more than 1 month
- •used drug to control the blood sugar with 3 weeks
- •diabetic ketosis,keto-acidosis,serious infection or trauma,major surgery within 1 month
- •liver or kidney insufficiency,lung insufficiency,heart failure,acute myocardial infarction or other serious primary disease
- •SBP/DBP >160mmHg/100 mmHg
- •serious chronic diabetic complication
- •chronic stomach-intestine disease,bad condition of the whole body
- •pregnancy,preparing to pregnant,or breast-feed stage women
- •allergic to TCM component
- •mental disease
- •allergic habitus
- •attending to other clinical test
- •attended this test before
- •bibulosity and/or mental active drug,drug abuse or depend
- •usually change the working environment,unstable live environment,etc.which will complied the inclusion
- •unstable dose or type of anti-hypertension drug
- •taking the drug or health food which will change the body weight
研究组 & 干预措施
controlled group
Placebo Comparator
Tang-min Lin analogue 6g,tid,po
干预措施: Tang-min Lin pill (Drug)
Tang-min Lin pill
Experimental
Tang-min Lin pills 6g,tid,po
干预措施: Tang-min Lin pill (Drug)
结局指标
主要结局
glycosylated hemoglobin
时间窗: 0 and 12weeks after treatment
次要结局
- fasting blood glucose,2-hour postprandial blood glucose,true insulin,TG,TG、LCL-C、HDL-C、BMI,waistline, hipline,TCM syndrome and sign(baseline and 12 week after treatment)
研究者
研究点 (4)
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