Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus (NCT01087242) | Clinical Trial Compass
UnknownPhase 3
Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus
China480 participantsStarted 2009-05
Plain-language summary
This is a randomized, doubled blind, dose-paralleled control, multi-centre clinical trail,to evaluate the efficacy of Tang-min-ling pills in the treatment of type 2 diabetes mellitus.
Who can participate
Age range30 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* initial treatment type 2 diabetic patient
* liver-stomach heat retention syndrome
* BMI ≥24kg/m2
* aged 30-65 years
* after screening stage(lifestyle intervention),Hba1C≥7.0%,FPG7.0-13.3mmol/L or PG2h\>11.1mmol/L;
* voluntary signs the informed consent
Exclusion Criteria:
* have used anti-diabetes drug before more than 1 month
* used drug to control the blood sugar with 3 weeks
* diabetic ketosis,keto-acidosis,serious infection or trauma,major surgery within 1 month
* liver or kidney insufficiency,lung insufficiency,heart failure,acute myocardial infarction or other serious primary disease
* SBP/DBP \>160mmHg/100 mmHg
* serious chronic diabetic complication
* chronic stomach-intestine disease,bad condition of the whole body
* pregnancy,preparing to pregnant,or breast-feed stage women
* allergic to TCM component
* mental disease
* allergic habitus
* attending to other clinical test
* attended this test before
* bibulosity and/or mental active drug,drug abuse or depend
* usually change the working environment,unstable live environment,etc.which will complied the inclusion
* unstable dose or type of anti-hypertension drug
* taking the drug or health food which will change the body weight
What they're measuring
1
glycosylated hemoglobin
Timeframe: 0 and 12weeks after treatment
Trial details
NCT IDNCT01087242
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences