Diabetic kidney disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria for DKD in G2A3; the estimated glomerular filtration rate is 60-89ml/min and UACR is>300mg/g or 24-hour urine protein quantitation is> 0.5 g;2) TCM syndrome differentiation is syndrome of spleen and kidney deficiency and dampness and blood stasis blocking collaterals;3) Age is 18-75 years old regardless of gender;4) Blood pressure is stable below 160/90mmHg; 5) 6.5%= glycated hemoglobin =11.0%; 6) 18.0 kg/m2= Body mass index (BMI) = 40.0 kg/m2; 7) Voluntary participation and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Proteinuria caused by other reasons such as chronic glomerulonephritis systemic lupus erythematosus Sjogren's syndrome etc.2) Patients who develop diabetic ketoacidosis hyperosmolar syndrome (HHS) infection and severe diabetic foot gangrene within one month.3) The 24-hour urine protein quantitation is greater than 5.0 g or UACR is greater than 3000mg/g.4) Renovascular hypertension.5) Patients with a critical and severe history of malignant hypertension myocardial infarction cerebrovascular accident etc. within six months and patients with congestive heart failure grades I-IV.6) Cancer pregnancy and allergies to relevant drugs in the treatment plan are not suitable for receiving this treatment plan.7) Suggest possible conditions with diabetes mellitus and other kidney diseases: no retinopathy; rapid decrease in estimated glomerular filtration rate (eGFR); sharp increase in proteinuria or nephrotic syndrome; urinary sediment activity and increased formed elements; symptoms or signs of other systemic diseases (such as autoimmune diseases); eGFR decrease by>30% within 2 to 3 months after initiation of treatment with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor antagonists (ARBs); Abnormal renal function but no significant proteinuria; nephrotic syndrome lasts for a long time (more than 1 year) but normal renal function.8) Women during pregnancy or lactation. 9) Patients participating in clinical trials of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urinary albumin to creatinine ratio;renal function;Cystatin C;TCM syndrome score;Quality of Life scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood lipid;glycated hemoglobin A1c;Pyroptosis markers;serum interleukin 1ß;Fasting blood glucose;serum interleukin 6; | — |
Countries
China
Contacts
Jiangsu Province Hospital on Integration of Chinese and Western Medicine