Diabetic kidney disease
Conditions
Interventions
text group:Placebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing
HuangKui Capsule 2.5g/tid, oral dosing.
Control group:irbesartan tablets 150mg /qd, oral dosing
Placebo drug that simulates HuangKui capsule 2.5g/tid, oral dosing.
Combined treatment group:irbesartan tablets 150mg /qd, oral dosing
Sponsors
Jiangsu Province hospital of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. Meet (WHO) diagnostic criteria for type 2 diabetes: Fasting blood glucose> 126 mg/dL (or> 7.0 mmol/L), 2 h postprandial> 200 mg/dL (or 11.1 mmol/L), or OGTT test 2h blood glucose> 200mg/dL (11.1mmol/L), random blood sugar = 200mg/dL (11.1mmol/L); 3.Meet Diabetic Kidney Disease (DKD) and the United States Diabetes Association (ADA) and the American Kidney Foundation (NKF) diagnostic criteria; 300mg / g = ACR <2000mg / g or 24-hour urinary protein quantitation in the 0.5g ~ 2.5g / g; 4.e-GFR=30mL/min(CKD-EPI formula), and serum creatinine <265.2umol / L (3mg / dl); 5.HbA1C = 8.5%; 6.Agree to sign informed consent form.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus; 2. Other secondary glomerulonephritis caused by Non-diabetes disease; 3. Taking Abelmoschus Huangkui capsule, ACEI and / or ARB drugs within one month before enrollment not been Screened; 4. Taking glucocorticoid, immunosuppressive agents and Tripterygium wilfordii drug history within one month; 5. Taking three or more antihypertensive drugs, but the blood pressure is still > 160 / 90mmHg; 6. Serum creatinine> baseline 150% during the 4-week screening period (Serum creatinine>baseline 150% within 1 week by repeated test); 7. With other diseases, syndromes, or comorbidities that may affect the diagnosis and therapeutic effect of the target indications; 8. The treatments received may affect the evaluation of efficacy and safety endpoints; 9. With phychological or pathological conditions which may affect the evaluation of efficacy endpoints and safety endpointssuch as the menstrual period, or heart, brain, liver and hematopoietic system and other serious primary disease; 10. With high risk, such as pregnant women or childbearing during the trial, be allergy to the Abelmoschus Huangkui Capsule and irbesartan,in the dangerous condition with unexpected accidents; 11. Alcohol or drug abuse; 12. Noncompliance, such as unwilling to accept research procedures or suffering from mental illness and other diseases; 13. Other: Such as poor compliance, or can not attend the follow-up visit in time for some reasons; 14. To be participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR;24-hour urine protein ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of glomerular filtration rate;high-sensitivity C-reactive protein;TCM syndromes outcome measures; | — |
Countries
China
Contacts
Public ContactWei Sun
Jiangsu Province hospital of TCM
Outcome results
None listed