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Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High Dose GGQL Decoction
Mild dose GGQL Decoction
Low dose GGQL Decoction
Placebo
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 Diabetes Mellitus, Type 2 focused on measuring Dose-Response Relationship, type 2 diabetes,TCM

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes mellitus
  • 30-65 years old
  • HbA1c≥7.0%, and FPG>7.0 mmol/L, but <13.9 mmol/L or 2hPG>11.1 mmol/L
  • Informed consent has been signed
  • Dampness and Heat in Spleen

Exclusion Criteria:

  • The patients accepted diabetic treatment for more than a month continuously
  • The patients were treated by drugs in 3 week before they were given test drugs
  • Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month
  • The contractive pressure >160 mmHg or diastolic pressure >100 mmHg
  • Pregnant, preparing for pregnancy or breast-feeding women
  • Mental patients
  • The patients whose ALT or AST are >100U/L,and BUN or Cr are abnormal.
  • The patients who have serious heart, lung, liver, kidney and brain or other primary complications
  • Allergic persons
  • The patients who are attending other clinical trial
  • The patients who have serious diabetic complications
  • The patients who ever attended this clinical trial
  • Alcohol and / or psychoactive substances, drug abuse and dependency
  • The person maybe loss for some reason such as work or life condition according to the investigator's judgement
  • The lipid-lowering or antihypertensive drug dosage and category which the patients are taking could not be kept stable
  • The patients who are eating some drugs or health food which can affect the body weight

Sites / Locations

  • Beijing Traditional Chinese Medicine Hospital of the Capital University of Medical SciencesRecruiting
  • China-Japan Friendship HospitalRecruiting
  • Ji Shui Tan Hospital of BeijingRecruiting
  • Dongzhimen Hospital Attached to Beijing Traditional Chinese Medicine UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

High dose GGQL Decoction

Mild dose GGQL Decoction

Low dose GGQL Decoction

Placebo

Arm Description

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)
blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests
Ins(0h,1h,2h),blood lipids

Full Information

First Posted
October 12, 2010
Last Updated
May 5, 2012
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01219803
Brief Title
Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes
Official Title
Dosage-efficacy Relationship Clinical Trial of Ge Gen Qin Lian Decoction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ge Gen Qin Lian Decoction are one kind of Chinese prescription, and previous study showed they had antidiabetic effects on the clinical patients and no obvious toxicity was found. The purpose of this study was to evaluate the efficacy and safety of different dosage of Ge Gen Qin Lian Decoction in the treatment of type 2 diabetic patients and explore relationship of the dosage and effect and the safety of 3 dosages of Ge Gen Qin Lian Decoction.
Detailed Description
two hundred and forty primary diabetic patients will be expected to be recruited, which were divided into different groups in a randomized, doubled blind, dose-paralleled-control multi-centre clinical design. The patients were randomly taken with high-dosage(5 times of low-dosage),mild-dosage(3 times of low-dosage), low-dosage,placebo(4.5% of low dosage) by 2 times every day for 12 weeks. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG),postprandial 2 hours plasma glucose(2hPG),insulin(0h,1h,2h),syndrome,symptoms,body mass index (BMI),waist circumference (WC) of these groups were measured and analyzed. Some safety indexes such blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and analyzed during the experiment. The treatment period is 12 week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug
Keywords
Dose-Response Relationship, type 2 diabetes,TCM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose GGQL Decoction
Arm Type
Experimental
Arm Title
Mild dose GGQL Decoction
Arm Type
Experimental
Arm Title
Low dose GGQL Decoction
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
High Dose GGQL Decoction
Other Intervention Name(s)
High Dose Ge Gen Qin Lian Decoction
Intervention Description
The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc,5 times thick of low dose GGQL Decoction, 150ml/bag, twice in a day
Intervention Type
Drug
Intervention Name(s)
Mild dose GGQL Decoction
Other Intervention Name(s)
Mild dose Ge Gen Qin Lian Decoction
Intervention Description
The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc,3 times thick of low dose GGQL Decoction, 150ml/bag, twice in a day
Intervention Type
Drug
Intervention Name(s)
Low dose GGQL Decoction
Other Intervention Name(s)
Low dose Ge Gen Qin Lian Decoction
Intervention Description
The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc, 150ml/bag, twice in a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo of Ge-Gen-Qin-Lian Decoction
Intervention Description
The placebo was a kind of decoction,which including 4.5% low dose GGQL Decoction to feel bitter taste as other drugs, 150ml/bag, twice in a day
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
12 weeks after treatment
Secondary Outcome Measure Information:
Title
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)
Time Frame
12 weeks after treatment
Title
blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests
Time Frame
12 weeks after treatment
Title
Ins(0h,1h,2h),blood lipids
Time Frame
12 weeks 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: Clinical diagnosis of type 2 diabetes mellitus 30-65 years old HbA1c≥7.0%, and FPG>7.0 mmol/L, but <13.9 mmol/L or 2hPG>11.1 mmol/L Informed consent has been signed Dampness and Heat in Spleen Exclusion Criteria: The patients accepted diabetic treatment for more than a month continuously The patients were treated by drugs in 3 week before they were given test drugs Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month The contractive pressure >160 mmHg or diastolic pressure >100 mmHg Pregnant, preparing for pregnancy or breast-feeding women Mental patients The patients whose ALT or AST are >100U/L,and BUN or Cr are abnormal. The patients who have serious heart, lung, liver, kidney and brain or other primary complications Allergic persons The patients who are attending other clinical trial The patients who have serious diabetic complications The patients who ever attended this clinical trial Alcohol and / or psychoactive substances, drug abuse and dependency The person maybe loss for some reason such as work or life condition according to the investigator's judgement The lipid-lowering or antihypertensive drug dosage and category which the patients are taking could not be kept stable The patients who are eating some drugs or health food which can affect the body weight
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng mei Lian, Ph.D
Phone
0086-010-88001402
Email
melonzhao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Lin Tong, Ph.D
Organizational Affiliation
Guang' anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Traditional Chinese Medicine Hospital of the Capital University of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bai Chang, Ph.D
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Xu, Ph.D
Facility Name
Ji Shui Tan Hospital of Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Wang, M.D
Facility Name
Dongzhimen Hospital Attached to Beijing Traditional Chinese Medicine University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongfang Liu, Ph.D

12. IPD Sharing Statement

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Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes

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