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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
  Purpose

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 Intervention Phase
Type 2 Diabetes
 Drug: Tang-min Lin pill
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 480
Study Start Date: May 2009
Estimated Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087242

Locations
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
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

No publications provided

Responsible Party: Department of drug clinical trail institution, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01087242     History of Changes
Other Study ID Numbers: 2008L00307
Study First Received: March 9, 2010
Last Updated: March 15, 2010
Health Authority: China: Food and Drug Administration

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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Contraceptives, Oral
 Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013