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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2009 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

Tianjin University of Traditional Chinese Medicine

Liaoning University of Traditional Chinese Medicine

Shanghai University of Traditional Chinese Medicine

Beijing Hospital

Tianjin Tasly Pharmaceutical Co., Ltd

Information provided by:

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

ClinicalTrials.gov Identifier:

NCT01087242

First received: March 9, 2010

Last updated: March 15, 2010

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2010

Last Updated Date

March 15, 2010

Start Date ^ICMJE

May 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

glycosylated hemoglobin [ Time Frame: 0 and 12weeks after treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01087242 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: Tang-min Lin pill

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

Study Arm (s)

Placebo Comparator: controlled group
Tang-min Lin analogue 6g,tid,po

Intervention: Drug: Tang-min Lin pill
Experimental: Tang-min Lin pill
Tang-min Lin pills 6g,tid,po

Intervention: Drug: Tang-min Lin pill

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

480

Estimated Completion Date

June 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01087242

Other Study ID Numbers ^ICMJE

2008L00307

Has Data Monitoring Committee

Responsible Party

Department of drug clinical trail institution, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Sponsor ^ICMJE

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators ^ICMJE

Tianjin University of Traditional Chinese Medicine
Liaoning University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Beijing Hospital
Tianjin Tasly Pharmaceutical Co., Ltd

Investigators ^ICMJE

Principal Investigator:	Wu S Tao, pro.	Tian Jin university of tradtional chinese medicine
Study Chair:	Lian F Mei, doctor	Guang'anmen Hospital of China Academy of Chinese Medical

Information Provided By

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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