Diabetic lower extremity vascular disease
Conditions
Interventions
Control group
:General treatment : two weeks before the start of treatment for diabetes diet life education
( 2 ) Symptomatic treatment : patients with dyslipidemia oral rosuvastatin, basic hypoglycemic regimen. On this basis, the control group was treated with traditional Chinese medicine placebo ( produce
test group:General treatment : two weeks before the start of treatment for diabetes diet life education
( 2 ) Symptomatic treatment : patients with dyslipidemia oral rosuvastatin, basic hypoglycemic regimen. The experimental group was treated with Danggui Liuhuang Decoction Granules on the basis of stan
Sponsors
Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: ( 1 ) Age>= 18 years old and < 80 years old ; ( 2 ) Diagnosed as type 2 diabetic lower extremity arterial disease, fasting plasma glucose ( FPG )<=9.0mmol / L and HbA1C < 8.5 % ; ( 3 ) Fontaine stage I, -III ; ( 4 ) In line with Yin Huowang TCM syndrome type ; ( 5 ) Voluntary to participate in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: ( 1 ) Exclusion of acute coronary heart disease, stroke and other acute diseases ; ( 2 ) Exclusion of Raynaud 's disease, thromboangiitis obliterans, acute arterial embolism and other limb arterial diseases ; ( 3 ) Patients who were known to be allergic to research drugs, or allergic to a variety of drugs ; ( 4 ) Previously diagnosed as type 1 diabetes ; ( 5 ) Previously diagnosed as severe arrhythmia, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate ; ( 6 ) Previously diagnosed as nephrotic syndrome, severe liver disease, Cushing 's syndrome and other diseases that significantly affect blood lipid levels. Glomerular filtration rate ( eGFR ) < 30ml / min / 1.73m^2 ( calculated by MDRD formula ) ; alanine aminotransferase ( ALT ) or aspartate aminotransferase ( AST ) more than 2 times the upper limit of normal value, or total bilirubin more than 1.5 times the upper limit of normal value ; creatine kinase exceeds 3 times the upper limit of normal value ; ( 7 ) Hyperthyroidism or hypothyroidism, defined as thyroid stimulating hormone below the lower limit of normal or more than 1.5 times the upper limit of normal ; ( 8 ) A history of malignant tumor within 5 years before screening ; ( 9 ) There was a history of major surgery within 3 months before screening or major surgery was planned during the study period ; ( 10 ) Long-term continuous or repeated use of systemic glucocorticoids within 3 months before screening ; ( 11 ) Patients with active infectious diseases, mental illness, pregnant women or lactating women, etc., at the time of screening or at random, were judged by the researchers not to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ABI;Glycated Hemoglobin A1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose;2-hour Postprandial Glucose;Fasting C-Peptide;Fasting Insulin;2-hour Postprandial Insulin;2-hour Postprandial C-Peptide;Glycated Albumin;Triglycerides);Total Cholesterol);Low-Density Lipoprotein Cholesterol;High-Density Lipoprotein Cholesterol;Small Dense Low-Density Lipoprotein Cholesterol;Apolipoprotein A-I;Apolipoprotein B;Apolipoprotein E;Free Fatty Acids;Nitric Oxide;Interleukin-6;Interleukin-1 beta;Tumor Necrosis Factor-alpha; C-Reactive Protein; Vascular Cell Adhesion Molecule-1; Vascular Endothelial Growth Factor;flow-mediated dilation;Methylglyoxal;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactLei Tao
Shanghai University of Traditional Chinese Medicine
Outcome results
None listed