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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborator: Tasly Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Patients with primary type 2 diabetes mellitus

2. BMI ≥ 24 kg•m-2

3. 30-70 years old

4. HbA1c≥7.0%, and FPG>7.0 mmol/L, but <13.9 mmol/L or 2hPG>11.1 mmol/L

5. Informed consent has been signed

6. stagnated heat of liver and stomach syndrome according to TCM syndrome differentiation

Exclusion Criteria:

1. The patients accepted diabetic treatment for more than a month continuously

2. The patients were treated by drugs in 3 week before they were given test drugs

3. Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month

4. The contractive pressure >160 mmHg or diastolic pressure >100 mmHg

5. Pregnant, preparing for pregnancy or breast-feeding women

6. Mental patients

7. The patients who have serious heart, lung, liver, kidney and brain or other primary complications

8. Allergic persons

9. The patients who are attending other clinical trial

10. The patients who have serious diabetic complications

11. The patients who ever attended this clinical trial

12. Alcohol and / or psychoactive substances, drug abuse and dependency

13. The person maybe loss for some reason such as work or life condition according to the investigator's judgement

14. The lipid-lowering or antihypertensive drug dosage and category which the patients are taking couldn't be kept stable

15. The patients who are eating some drugs or health food which can affect the body weight