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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01219803
Other study ID # 20100727
Secondary ID
Status Recruiting
Phase N/A
First received October 12, 2010
Last updated May 5, 2012
Start date August 2010
Est. completion date August 2014

Study information

Verified date May 2012
Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact Feng mei Lian, Ph.D
Phone 0086-010-88001402
Email melonzhao@163.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Intervention

Drug:
High Dose GGQL Decoction
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
Mild dose GGQL Decoction
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
Low dose GGQL Decoction
The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc, 150ml/bag, twice in a day
Placebo
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

Locations

Country Name City State
China Beijing Traditional Chinese Medicine Hospital of the Capital University of Medical Sciences Beijing Beijing
China China-Japan Friendship Hospital Beijing Beijing
China Dongzhimen Hospital Attached to Beijing Traditional Chinese Medicine University Beijing Beijing
China Ji Shui Tan Hospital of Beijing Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c 12 weeks after treatment No
Secondary Fasting plasma glucose (FPG)?postprandial 2 hours plasma glucose(2hPG) 12 weeks after treatment No
Secondary blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests 12 weeks after treatment Yes
Secondary Ins(0h,1h,2h),blood lipids 12 weeks after treatment No
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