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

Type 2 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01087242
• Other study ID #: 2008L00307
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 9, 2010
• Last updated: March 15, 2010
• Start date: May 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2009
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Tang-min Lin pill
Tang-min Lin pill 6g,tid,treat 12 weeks.

Locations

Country	Name	City	State
China	TCM school of Jiang Su province	Nan Jing	Jiang Su
China	Shanghai University of Traditional Chinese Medicine	Shang Hai	Shang Hai
China	Liaoning University of Traditional Chinese Medicine	Shen Yang	Liao Ning
China	Tian Jin traditional chinese medicine university	Tian Jin	Tian Jin

Sponsors (6)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycosylated hemoglobin		0 and 12weeks after treatment	Yes
Secondary	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	Yes