diabetic nephropathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the DKD diagnostic criteria in the 2021 Chinese Guidelines for Clinical Diagnosis and Treatment of Diabetic Kidney Disease; (2) e-GFR=45mL/min (CKD-EPI formula) and no blood purification treatment; (3) Meet any of the following: A. 24-hour urine protein quantification greater than or equal to 0.5g; b. Meet the diagnostic criteria of damp-heat syndrome in the Guiding Principles for Clinical Research of New Traditional Chinese Medicine for the Treatment of Chronic Kidney Disease; (4) Meet the diagnostic criteria of type 2 diabetes in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition); (5) Age over 18 gender not limited; (6) The subject has informed consent and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Other secondary nephritis not caused by diabetes such as lupus nephritis allergic purpura nephritis systemic small vessel inflammatory renal damage hypertensive nephropathy gouty nephropathy myeloma nephropathy etc.; (2) Using Huangkui capsules within 1 month before enrollment; (3) Those with allergic constitution or known allergy to the components of this drug; (4) The patient has severe diseases and functional disorders of other organs and life-threatening complications such as severe infection; (5) Patients with acute central nervous system disease severe gastrointestinal disease history of HIV infection history of mental illness history of malignant tumor and other advanced diseases; (6) Pregnant or lactating women; (7) Participating in another clinical study of a drug or device that has not yet reached the primary endpoint; (8) Using glucocorticoids immunosuppressive drugs or leech preparations within 1 month or undergoing the above treatment; (9) Taking other traditional Chinese medicines and decoctions related to kidney disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative 24-hour urine protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of end event or cardiorenal complications;Blood urea nitrogen;G. F. R;Hyper-sensitive C-reactive protein;Serum cystatin (Cys)-C;Uric acid/creatinine ratio;blood fat;glycosylated hemoglobin; | — |
Countries
china
Contacts
Henan University of Traditional Chinese Medicine