Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule

Study Overview
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Brief Summary
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Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history. aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo Capsule to treat type II diabetes mellitus. ---Preliminary evaluate the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes

Detailed Description
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Preliminary evaluation on the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes, and provides basis for determining optimal dosage of Tangning Tongluo capsule.

Official Title
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Phase 2 Study of The Optimal Dosage of Tang Ning Tongluo Capsule for Type II Diabetes

Conditions
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Accidental Exposure While Preparing Drug for Administration

Intervention / Treatment
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* Drug: TNTL capsule
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfilled diagnostic criteria for type II diabetes and TCM syndrome diagnostic criteria. Age between 18-70 years. The blood sugar meet the following criteria: fasting blood glucose ≥ 7.0mmol/L, ≤ 13 mmol/L and (or) ≥ 2 hour postprandial blood glucose 11.1 mmol/L, ≤ 16 mmol/L; eligible conditions in blood glucose, glycosylated hemoglobin to ≤ 10%. Traditional Chinese medicine symptom score ≥ 4 points. Participated in the experiment voluntarily, and signed the informed consent form. Exclusion Criteria: Durring the cleaning period, blood sugar dropped to below detection diagnosis value through diet, increasing activity. Secondary diabetes mellitus or nearly a month using insulin; or is the use of insulin sensitizers (thiazolidine two ketones), repaglinide, Bernard Glenn Nai, alpha glucoside enzyme inhibitor (acarbose, voglibose), other traditional Chinese medicine. Within the past 1 months, with diabetic ketoacidosis and other acute metabolic disorders. ALT is 2 times higher than the upper limit of the normal value, Cr is higher than the upper limit of normal persons. Has severe heart, liver, renal, hematopoietic system disease, or other serious diseases and mental disease patients. Pregnant, lactating women and prepare for pregnancy. The allergic constitution and the drug allergy known composition. For nearly a month with severe infection or other emergency state, such as trauma, operation etc.. within the past 3 months, participated in the other drugs.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNTL capsule and Placebo<br>3-4 capsules 3 times a day Used before meals | Drug: TNTL capsule<br>* Patients were asked to taken drugs 3 times a day, with each time 3 grains<br>* Other names: Tang Ning Tongluo Capsule;Drug: Placebo<br>* Patients were asked to taken drugs 3 times a day, with each time 3 grains<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decline glycosylated hemoglobin A1C and blood glucose level | Decline in Hemoglobin A1C and blood glucose level | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical composite safety evaluation of Tangning Tongluo Capsule in the treatment of type II diabetes participants | Routine check for blood, urine, stool + occult blood, liver function (ALT, AST, AKP, GGT, TBIL), renal function (BuN, Cr), ECG before treatment with 1 times per week. | 2 months |