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
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
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
NCT ID
NCT01087242
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
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
Learn more about this trial
Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus
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