Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug
Conditions
Keywords
Dose-Response Relationship, type 2 diabetes,TCM
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.
Interventions
DRUGHigh 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
DRUGMild 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
DRUGLow dose GGQL Decoction
The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc, 150ml/bag, twice in a day
DRUGPlacebo
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
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | 12 weeks after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG) | 12 weeks after treatment |
| blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests | 12 weeks after treatment |
| Ins(0h,1h,2h),blood lipids | 12 weeks after treatment |
Countries
China
Contacts
Primary ContactFeng mei Lian, Ph.D
Outcome results
None listed