ISRCTN90063632
Completed
Not Applicable
Research on the comprehensive therapy for impaired glucose tolerance (IGT) by traditional Chinese medicine
Ministry of Science and Technology of the People's Republic of China (China)0 sites2,000 target enrollmentStarted: July 10, 2008Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ministry of Science and Technology of the People's Republic of China (China)
- Enrollment
- 2,000
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\. Both males and females
- •2\. 25 \=\< age \<\=70
- •3\. Intravenous plasma glucose: Fasting plasma glucose (FPG) \<7\.0 mmol/L and 2\-hour plasma glucose (2hPG) of oral glucose tolerance test (OGTT) \<11\.1 mmol/L, \>\=7\.8 mmol/L
- •4\. Deficiency of both qi and yin syndromes accompanied by heat
- •5\. Taking no medicine for treatment of IGT
- •6\. 18\.5 kg/m2 \< body mass index (BMI) \<30 kg/m2
- •7\. Voluntariness, and signed letter of consent
- •8\. Those who do not take part in any other trails within 3 months
Exclusion Criteria
- •1\. Acute cardiovascular disease and myocardial infarction within 6 months
- •2\. Proliferative retinopathy that needs to be treated by laser
- •3\. Not compliant
- •4\. Mental disease
- •5\. Pregnant or lactating women; women without contraception
- •6\. Allergic to any traditional chinese medicine
- •7\. Co\-morbid with other endocrine disease or serious protopathy
- •8\. Systolic blood pressure (SBP) \>\= 160 mmHg, diastolic blood pressure (DBP) \>\= 100 mmHg and secondary hypertension
- •9\. Cholesterol (CHO) \>\= 6\.22 mmol/L(240 mg/dl) or low density lipoprotein (LDL) \>\= 4\.14 mmol/L (160 mg/dl)
- •10\. Patients who are treated by other hypoglycemic drug
Investigators
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