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

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Beijing Hospital; Liaoning University of Traditional Chinese Medicine; Shanghai University of Traditional Chinese Medicine; Tianjin Tasly Pharmaceutical Co., Ltd; Tianjin University of Traditional Chinese Medicine

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