Diabetic kidney disease
Conditions
Interventions
Experimental group:Chen's Tangshen Recipe
Control group:placebo
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) DKD patients with clinical diagnosis of CKD stage 3~4 (2) Aged 18 to 80 years old; (3)Patients with type 2 diabetes who have been taking antidiabetic drugs or insulin treatment for half a year or more, with HbA1c=8%; (4) Patients with 24-hour urine protein quantification=0.3g (5)The patients were informed and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes; 2. Abnormal liver function test results (AST or ALT or alkaline phosphatase > 3 times ULN), or other known patients with acute and chronic active hepatitis and cirrhosis; 3. Previous history of EGFR decline > 30% within 2-3 months after using ACEI / ARB drugs; 4. Those who use hormone or immunosuppressant due to kidney disease or kidney transplantation; 5. Other chronic kidney diseases (such as chronic glomerulonephritis, chronic pyelonephritis, ischemic kidney disease, etc.) during screening; 6. Patients with blood pressure lower than 110 / 60mmHg (without antihypertensive drugs) before screening; 7. Those whose blood pressure was continuously higher than 180 / 100mmHg two weeks before screening; 8. Those with blood potassium level > 5.5 mmol / L during screening; 9. Patients with severe acute diabetes complications (ketoacidosis, lactic acidosis, hypertonic nonketotic diabetes coma, hypoglycemic coma) within 6 months before screening; 10. Patients with acute coronary syndrome, heart failure (NYHA score III-IV), or surgical treatment for heart related diseases, stroke or poor prognosis of stroke within the first 3 months of screening; 11. Those who have a history of mental illness or language disorder before screening and are unable to cooperate or unwilling to cooperate; 12. History of autoimmune diseases (such as systemic lupus erythematosus) before screening; 13. Those with a history of malignant tumor disease within the previous two years were screened 14. HIV patients; 15. Those who are allergic to the test drug; 16. Those who are participating in clinical trials of other drugs or who have participated in other drug trials within 3 months before screening (refer to those who are enrolled in the group and receive treatment of test drugs); 17. Female patients with pregnancy plan, pregnancy or lactation within half a year; 18. Other conditions that the investigator judges are not suitable for this test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urinary protein quantity;24-hour urinary microalbumin;Glomerular filtration rate;Urinary albumin-creatinine ratio;fasting plasma glucose; | — |
Countries
China
Contacts
Public ContactZhang Xianwen
Outcome results
None listed