Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Tang-min Lin pill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01087242

2008L00307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 2 patient groups, including a placebo group

controlled group

Placebo Comparator group

Description:

Tang-min Lin analogue 6g,tid,po

Treatment:

Drug: Tang-min Lin pill

Tang-min Lin pill

Experimental group

Description:

Tang-min Lin pills 6g,tid,po

Treatment:

Drug: Tang-min Lin pill