Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule (TNTL)

Guizhou Bailing Group Pharmaceutical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Accidental Exposure While Preparing Drug for Administration

Treatments: Drug: TNTL capsule; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02161276

TNTL-14-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Fulfilled diagnostic criteria for type II diabetes and TCM syndrome diagnostic criteria.
2. Age between 18-70 years.
3. 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%.
4. Traditional Chinese medicine symptom score ≥ 4 points.
5. Participated in the experiment voluntarily, and signed the informed consent form.

Exclusion criteria

1. Durring the cleaning period, blood sugar dropped to below detection diagnosis value through diet, increasing activity.
2. 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.
3. Within the past 1 months, with diabetic ketoacidosis and other acute metabolic disorders.
4. ALT is 2 times higher than the upper limit of the normal value, Cr is higher than the upper limit of normal persons.
5. Has severe heart, liver, renal, hematopoietic system disease, or other serious diseases and mental disease patients.
6. Pregnant, lactating women and prepare for pregnancy.
7. The allergic constitution and the drug allergy known composition.
8. For nearly a month with severe infection or other emergency state, such as trauma, operation etc..
9. within the past 3 months, participated in the other drugs.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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110 participants in 1 patient group

TNTL capsule and Placebo

Experimental group

Description:

3-4 capsules 3 times a day Used before meals

Treatment:

Drug: Placebo

Drug: TNTL capsule