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

March 9, 2010
March 15, 2010
May 2009
December 2009   (final data collection date for primary outcome measure)
glycosylated hemoglobin [ Time Frame: 0 and 12weeks after treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01087242 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
Drug: Tang-min Lin pill
Tang-min Lin pill 6g,tid,treat 12 weeks.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
480
June 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01087242
2008L00307
No
Department of drug clinical trail institution, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  • 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
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
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
May 2009

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