Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dosage-efficacy Relationship Clinical Trial of Ge Gen Qin Lian Decoction

Conditions
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Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug

Intervention / Treatment
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* Drug: High Dose GGQL Decoction
* Drug: Mild dose GGQL Decoction
* Drug: Low dose GGQL Decoction
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

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 |
| --- | --- |
| Experimental: High dose GGQL Decoction<br> | Drug: High Dose GGQL Decoction<br>* The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc,5 times thick of low dose GGQL Decoction, 150ml/bag, twice in a day<br>* Other names: High Dose Ge Gen Qin Lian Decoction;|
| Experimental: Mild dose GGQL Decoction<br> | Drug: Mild dose GGQL Decoction<br>* The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc,3 times thick of low dose GGQL Decoction, 150ml/bag, twice in a day<br>* Other names: Mild dose Ge Gen Qin Lian Decoction;|
| Experimental: Low dose GGQL Decoction<br> | Drug: Low dose GGQL Decoction<br>* The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc, 150ml/bag, twice in a day<br>* Other names: Low dose Ge Gen Qin Lian Decoction;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* The placebo was a kind of decoction,which including 4.5% low dose GGQL Decoction to feel bitter taste as other drugs, 150ml/bag, twice in a day<br>* Other names: placebo of Ge-Gen-Qin-Lian Decoction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 12 weeks after treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dose-Response Relationship, type 2 diabetes,TCM