Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Dosage-efficacy Relationship Clinical Trial of Ge Gen Qin Lian Decoction
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
China,
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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