Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-center Randomized Controled and Double Blind Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Tang-min-ling pills low dosage
* Drug: Tang-min-ling pills high dosage
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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: placebo<br>Tang-min Lin pills analogue | Drug: Placebo<br>* Tang-min-Ling pills analogue 6g,tid,po<br>* Other names: Tang-min-Ling pills analogue;|
| Experimental: Tang-min-ling pills high dosage<br>Tang-min-ling pills, high dosage, 12g, tid po | Drug: Tang-min-ling pills high dosage<br>* high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.<br>* Other names: Tang min lin pills;|
| Experimental: Tang-min-ling pills low dosage<br>low dosage group:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks. | Drug: Tang-min-ling pills low dosage<br>* low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.<br>* Other names: Tang min lin pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c (HbA1c) | The HbA1c was measured and analyzed twice, one is before the treatment and the other is 12 weeks aftertreatment to make a self comparison. | 12 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、body mass index (BMI)、waist circumference (WC) |  | 12 weeks after treatment | 
| symptoms score and Chinese syndrome |  | 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 | The number of participants with adverse events were recorded and compared. The blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and observe the safety. | 12 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tang-min-ling pills;, overweight type 2 diabetes mellitus;, blood glucose, Traditional Chinese Medicine, Clinical Trial, Intervention Studies