Accidental Exposure While Preparing Drug for Administration
Conditions
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.
Interventions
DRUGTNTL capsule
Patients were asked to taken drugs 3 times a day, with each time 3 grains
DRUGPlacebo
Patients were asked to taken drugs 3 times a day, with each time 3 grains
Sponsors
China-Japan Friendship Hospital
Guizhou Bailing Group Pharmaceutical Co Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The decline glycosylated hemoglobin A1C and blood glucose level | up to 8 weeks | Decline in Hemoglobin A1C and blood glucose level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The clinical composite safety evaluation of Tangning Tongluo Capsule in the treatment of type II diabetes participants | 2 months | 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. |
Countries
China
Outcome results
None listed