| Trial ID: | L6531 |
| Source ID: | NCT01107171
|
| Associated Drug: |
Tang-Min-Ling Pills Low Dosage
|
| Title: |
Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Tang-min-ling pills low dosage|DRUG: Tang-min-ling pills high dosage|DRUG: Placebo
|
| Outcome Measures: |
Primary: Hemoglobin A1c (HbA1c), The HbA1c was measured and analyzed twice, one is before the treatment and the other is 12 weeks aftertreatment to make a self comparison., 12 weeks after treatment | Secondary: Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、body mass index (BMI)、waist circumference (WC), 12 weeks after treatment|symptoms score and Chinese syndrome, 12 weeks after treatment|The rate of adverse events,the blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests, The number of participants with adverse events were recorded and compared. The blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and observe the safety., 12 weeks after treatment
|
| Sponsor/Collaborators: |
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Collaborators: Tasly Pharmaceuticals, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
210
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-05
|
| Completion Date: |
2008-12
|
| Results First Posted: |
|
| Last Update Posted: |
2010-04-21
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| Locations: |
The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, 130041, China|Jilin Hospital of Integrated Traditional and Western Medicine, Changchun, 132001, China|Shanghai Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China|The Affiliated Hospital to Liaoning University of Traditional Chinese Medicine, Shenyang, China|The Second Affiliated Hospital to Liaoning University of TCM, Shenyang, China|First Teaching Hospital of Tianjin University of TCM, Tianjin, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01107171
|
