This trial is active, not recruiting.

Condition type 2 diabetes
Treatment tang-min lin pill
Phase phase 3
Sponsor Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborator Tianjin University of Traditional Chinese Medicine
Start date May 2009
End date December 2009
Trial size 480 participants
Trial identifier NCT01087242, 2008L00307


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Placebo Comparator)
Tang-min Lin analogue 6g,tid,po
tang-min lin pill
Tang-min Lin pill 6g,tid,treat 12 weeks.
Tang-min Lin pills 6g,tid,po
tang-min lin pill
Tang-min Lin pill 6g,tid,treat 12 weeks.

Primary Outcomes

glycosylated hemoglobin
time frame: 0 and 12weeks after treatment

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 30 years up to 65 years old.

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

Additional Information

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)
Principal investigator Wu S Tao, pro.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.