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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tang-min Lin pill
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Tang-min Lin pills, type 2 diabetes, liver and stomach heat retention, Evaluate the safety and efficacy of Tang-min Lin pills

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TCM school of Jiang Su province
  • Liaoning University of Traditional Chinese Medicine
  • Shanghai University of Traditional Chinese Medicine
  • Tian Jin traditional chinese medicine university

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

controlled group

Tang-min Lin pill

Arm Description

Tang-min Lin analogue 6g,tid,po

Tang-min Lin pills 6g,tid,po

Outcomes

Primary Outcome Measures

glycosylated hemoglobin

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

Full Information

First Posted
March 9, 2010
Last Updated
March 15, 2010
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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
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1. Study Identification

Unique Protocol Identification Number
NCT01087242
Brief Title
Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus
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 Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Tang-min Lin pills, type 2 diabetes, liver and stomach heat retention, Evaluate the safety and efficacy of Tang-min Lin pills

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
controlled group
Arm Type
Placebo Comparator
Arm Description
Tang-min Lin analogue 6g,tid,po
Arm Title
Tang-min Lin pill
Arm Type
Experimental
Arm Description
Tang-min Lin pills 6g,tid,po
Intervention Type
Drug
Intervention Name(s)
Tang-min Lin pill
Intervention Description
Tang-min Lin pill 6g,tid,treat 12 weeks.
Primary Outcome Measure Information:
Title
glycosylated hemoglobin
Time Frame
0 and 12weeks after treatment
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu S Tao, pro.
Organizational Affiliation
Tian Jin university of tradtional chinese medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lian F Mei, doctor
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical
Official's Role
Study Chair
Facility Information:
Facility Name
TCM school of Jiang Su province
City
Nan Jing
State/Province
Jiang Su
ZIP/Postal Code
210029
Country
China
Facility Name
Liaoning University of Traditional Chinese Medicine
City
Shen Yang
State/Province
Liao Ning
ZIP/Postal Code
116600
Country
China
Facility Name
Shanghai University of Traditional Chinese Medicine
City
Shang Hai
State/Province
Shang Hai
ZIP/Postal Code
200032
Country
China
Facility Name
Tian Jin traditional chinese medicine university
City
Tian Jin
State/Province
Tian Jin
ZIP/Postal Code
300193
Country
China

12. IPD Sharing Statement

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

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