Clinical trial NCT01087242: Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus
Official title: Randomized，Double-blind，Dose Parallel Controlled, Multicentre Clinical Trail of Tang-min-Ling Pills and Placebo in Diabetes Mellitus(Liver-stomach Heat Retention Syndrome) (Phase Ⅲ)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Tang-min Lin pills
type 2 diabetes
liver and stomach heat retention
Evaluate the safety and efficacy of Tang-min Lin pills
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Tianjin University of Traditional Chinese Medicine
name: Liaoning University of Traditional Chinese Medicine
name: Shanghai University of Traditional Chinese Medicine
name: Beijing Hospital
name: Tianjin Tasly Pharmaceutical Co., Ltd
First posted: 2010-03-16
Enrollment: 480
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Type 2 diabetes mellitus combined liver-stomach heat retension syndrome were recruited, which were divided into 3 groups .The patients were randomly taken with high-dosage (12g Tang-min-ling pills every time), low-dosage (6g Tang-min-ling pills every time), placebo by 3 times every day for 12 weeks.

Eligibility criteria: 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

Primary outcomes:
measure: glycosylated hemoglobin
timeFrame: 0 and 12weeks after treatment
Secondary outcomes:
measure: fasting blood glucose,2-hour postprandial blood glucose,true insulin,TG,TG、LCL-C、HDL-C、BMI,waistline, hipline,TCM syndrome and sign
timeFrame: baseline and 12 week after treatment
Other outcomes:
Locations:
city: Nan Jing
country: China
facility: TCM school of Jiang Su province
state: Jiang Su
city: Shen Yang
country: China
facility: Liaoning University of Traditional Chinese Medicine
state: Liao Ning
city: Shang Hai
country: China
facility: Shanghai University of Traditional Chinese Medicine
state: Shang Hai
city: Tian Jin
country: China
facility: Tian Jin traditional chinese medicine university
state: Tian Jin
Study officials:
affiliation: Tian Jin university of tradtional chinese medicine
name: Wu S Tao, pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical
name: Lian F Mei, doctor
role: STUDY_CHAIR
References: