Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087242
Recruitment Status : Unknown
Verified May 2009 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : March 16, 2010
Last Update Posted : March 16, 2010
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tang-min Lin pill Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : May 2009
Actual Primary Completion Date : December 2009
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: controlled group
Tang-min Lin analogue 6g,tid,po
 Drug: Tang-min Lin pill
Tang-min Lin pill 6g,tid,treat 12 weeks.
Experimental: Tang-min Lin pill
Tang-min Lin pills 6g,tid,po
 Drug: Tang-min Lin pill
Tang-min Lin pill 6g,tid,treat 12 weeks.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. glycosylated hemoglobin [ Time Frame: 0 and 12weeks after treatment ]

Secondary Outcome Measures :
  1. 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087242


Locations
Layout table for location information
China, Jiang Su
TCM school of Jiang Su province
Nan Jing, Jiang Su, China, 210029
China, Liao Ning
Liaoning University of Traditional Chinese Medicine
Shen Yang, Liao Ning, China, 116600
China, Shang Hai
Shanghai University of Traditional Chinese Medicine
Shang Hai, Shang Hai, China, 200032
China, Tian Jin
Tian Jin traditional chinese medicine university
Tian Jin, Tian Jin, China, 300193
Sponsors and Collaborators
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
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Department of drug clinical trail institution, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01087242    
Other Study ID Numbers: 2008L00307
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: March 16, 2010
Last Verified: May 2009
Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Tang-min Lin pills
type 2 diabetes
liver and stomach heat retention
Evaluate the safety and efficacy of Tang-min Lin pills
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases