Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule

Phase 1

Completed

• Conditions: Accidental Exposure While Preparing Drug for Administration
• Interventions: Drug: TNTL capsule; Drug: Placebo

• Registration Number: NCT02161276
• Lead Sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Primary Completion: 2014-08
• Status Verified: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TNTL capsule and Placebo	Placebo	3-4 capsules 3 times a day Used before meals
TNTL capsule and Placebo	TNTL capsule	3-4 capsules 3 times a day Used before meals

Primary Outcome Measures

Name	Time	Method
The decline glycosylated hemoglobin A1C and blood glucose level	up to 8 weeks	Decline in Hemoglobin A1C and blood glucose level

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tianyuan Hospital of Guiyang City; 🇨🇳 Guiyang, Guizhou, China