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

Phase 3

• Conditions: Type 2 Diabetes
• Interventions: Drug: Tang-min Lin pill

• Registration Number: NCT01087242
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Timeline

• Status Verified: 2009-05
• Study Start: 2009-05
• Primary Completion: 2009-12
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-15
• Last Update Submitted: 2010-03-15
• Study First Posted: 2010-03-16
• Last Update Posted: 2010-03-16
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controlled group	Tang-min Lin pill	Tang-min Lin analogue 6g,tid,po
Tang-min Lin pill	Tang-min Lin pill	Tang-min Lin pills 6g,tid,po

Primary Outcome Measures

Name	Time	Method
glycosylated hemoglobin	0 and 12weeks after treatment

Secondary Outcome Measures

Name	Time	Method
fasting blood glucose,2-hour postprandial blood glucose,true insulin,TG,TG、LCL-C、HDL-C、BMI,waistline, hipline,TCM syndrome and sign	baseline and 12 week after treatment

Trial Locations

Locations (4)

Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shang Hai, Shang Hai, China

Tian Jin traditional chinese medicine university; 🇨🇳 Tian Jin, Tian Jin, China

TCM school of Jiang Su province; 🇨🇳 Nan Jing, Jiang Su, China

Liaoning University of Traditional Chinese Medicine; 🇨🇳 Shen Yang, Liao Ning, China