Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Tang-min Lin pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: controlled group<br>Tang-min Lin analogue 6g,tid,po | Drug: Tang-min Lin pill<br>* Tang-min Lin pill 6g,tid,treat 12 weeks.<br>|
| Experimental: Tang-min Lin pill<br>Tang-min Lin pills 6g,tid,po | Drug: Tang-min Lin pill<br>* Tang-min Lin pill 6g,tid,treat 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycosylated hemoglobin |  | 0 and 12weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tang-min Lin pills, type 2 diabetes, liver and stomach heat retention, Evaluate the safety and efficacy of Tang-min Lin pills