Clinical trial NCT02161276: Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule
Official title: Phase 2 Study of The Optimal Dosage of Tang Ning Tongluo Capsule for Type II Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Accidental Exposure While Preparing Drug for Administration
Lead sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
Collaborators: name: China-Japan Friendship Hospital
First posted: 2014-06-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The decline glycosylated hemoglobin A1C and blood glucose level
timeFrame: up to 8 weeks
Secondary outcomes:
measure: The clinical composite safety evaluation of Tangning Tongluo Capsule in the treatment of type II diabetes participants
timeFrame: 2 months
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Tianyuan Hospital of Guiyang City
state: Guizhou
Study officials:
affiliation: ICMJE
name: XY Xin, Dr.
role: STUDY_DIRECTOR
References: