Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule (TNTL)
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
Accidental Exposure While Preparing Drug for Administration
Drug: TNTL capsule
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of The Optimal Dosage of Tang Ning Tongluo Capsule for Type II Diabetes|
- The decline glycosylated hemoglobin A1C [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]Decline in Hemoglobin A1C
- Decline in blood glucose level of the patients [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
- The clinical composite safety evaluation of Tangning Tongluo Capsule in the treatment of type II diabetes participants [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: TNTL capsule and Placebo
3-4 capsules 3 times a day Used before meals
Drug: TNTL capsule
Patients were asked to taken drugs 3 times a day, with each time 3 grains
Other Name: Tang Ning Tongluo CapsuleDrug: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02161276
|Contact: Wenshu Teng, M.D||+868533412256|
|Tianyuan Hospital of Guiyang City||Recruiting|
|Guiyang, Guizhou, China, 550007|
|Contact: Wenshu Teng, M.D +868533412256|
|Study Director:||XY Xin, Dr.||ICMJE|