Accidental Exposure While Preparing Drug for Administration Clinical Trial
— TNTLOfficial title:
Phase 2 Study of The Optimal Dosage of Tang Ning Tongluo Capsule for Type II Diabetes
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
| Status | Completed |
| Enrollment | 110 |
| Est. completion date | September 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Tianyuan Hospital of Guiyang City | Guiyang | Guizhou |
| Lead Sponsor | Collaborator |
|---|---|
| Guizhou Bailing Group Pharmaceutical Co Ltd | China-Japan Friendship Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The decline glycosylated hemoglobin A1C and blood glucose level | Decline in Hemoglobin A1C and blood glucose level | up to 8 weeks | No |
| Secondary | 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 | Yes |