Type 2 diabetes
Conditions
Sponsors
Beijing Shijitan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes mellitus diagnosed according to the World Health Organization (WHO) standard in 1999; 2. meet the diagnostic criteria of TCM syndrome of diabetic nephropathy in the guiding principles of clinical research of new Chinese medicine (2002 Edition); 3. Aged 18 to 75 years old men and women; 4. HbA1c 5.8% - 10% (including both ends); blood pressure 60 ml / min (calculated by EPI formula); 7. Receive a stable dose of medication for 8 consecutive weeks prior to the second visit to control hypertension, hyperglycemia and (if applicable) dyslipidemia; 8. The dosage of angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) was stable for 8 weeks before the second visit; 9. Be able to understand and follow the research process, participate in the research voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to test drug or related drug; 2. Participated in this experiment. Participation is defined as accepting random assignment; 3. Women who are pregnant, lactating or planning their pregnancies, or women who are fertile and do not take effective contraceptive measures; 4. Participated in any clinical trials of approved or not approved trial drugs within 30 days before screening; 5. Any disease determined by the researcher that may endanger the safety of the subject or affect the compliance with the study protocol; 6. Congenital or hereditary nephropathy, including polycystic kidney disease, autoimmune kidney disease (including glomerulonephritis), or congenital urinary tract malformation or urinary tract infection, or urolithiasis or gout; 7. Use traditional Chinese medicine for diabetic nephropathy within 30 days before screening; 8. Myocardial infarction, stroke, unstable angina or transient ischemic attack occurred within 60 days before screening; 9. Heart failure currently classified as NYHA grade IV; 10. Planned revascularization of coronary, carotid or peripheral arteries; 11. Current (or within 90 days) long-term or intermittent hemodialysis or peritoneal dialysis; 12. He is currently suffering from malignant tumor or has suffered from malignant tumor within 5 years before screening. Except basal cell and squamous cell skin cancer and carcinoma in situ; 13. Have received or are waiting for solid organ transplantation; 14. Combined use of angiotensin converting enzyme (ACE) inhibitor and angiotensin II receptor antagonist (ARB); 15. Type 1 diabetes mellitus and special type diabetes mellitus; 16. Liver enzymes (AST, ALT or ALP) increased more than 3 times, or patients with liver disease could not participate in this study; 17. Routine urine test: hematuria + + or above or WBC exceeding normal range; 18. Other system diseases (blood, digestion, respiration, circulation, mental nerve, etc.) are not suitable for the test; 19. Alcoholics and drug abusers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CM syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| urinary albumin / creatinine ratio;estimated glomerular filtration rate;diabetes specific quality of life;glycosylated hemoglobin; | — |
Countries
China
Contacts
Public ContactXingzhong Feng/Jiang Min
Beijing Shijitan Hospital Affiliated to Capital Medical University
Outcome results
None listed