Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule

NCT ID: NCT02161276

Last Updated: 2014-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-09-30

Brief Summary

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

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.

Conditions

Accidental Exposure While Preparing Drug for Administration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TNTL capsule and Placebo

3-4 capsules 3 times a day Used before meals

Group Type: EXPERIMENTAL

TNTL capsule

Intervention Type: DRUG

Patients were asked to taken drugs 3 times a day, with each time 3 grains

Placebo

Intervention Type: DRUG

Patients were asked to taken drugs 3 times a day, with each time 3 grains

Interventions

TNTL capsule

Patients were asked to taken drugs 3 times a day, with each time 3 grains

Intervention Type: DRUG

Placebo

Patients were asked to taken drugs 3 times a day, with each time 3 grains

Intervention Type: DRUG

Other Intervention Names

Tang Ning Tongluo Capsule

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Guizhou Bailing Group Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

XY Xin, Dr.

Role: STUDY_DIRECTOR

ICMJE

Locations

Tianyuan Hospital of Guiyang City

Guiyang, Guizhou, China

Countries

China

Other Identifiers

TNTL-14-01

Identifier Type: -

Identifier Source: org_study_id