Diabetic kidney disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meets the clinical diagnostic criteria for diabetic nephropathy; 2) Aged 18–75 years, any gender; 3) eGFR >45 ml/min/1.73m²; 4) 24-hour urine protein <2.0 g/day; 5) Exhibits Traditional Chinese Medicine patterns of deficiency, stasis, or rheumatic symptoms; 6) Willing to participate in the study, able to attend regular follow-ups, and provide informed consent; 7) Has maintained a stable basic treatment plan (including hypoglycemic, antihypertensive, and lipid-lowering therapies) for =1 month prior to enrollment; during the first 3 months after enrollment, ARB, finerenone, and SGLT2 inhibitor therapies should generally not be adjusted.
Exclusion criteria
Exclusion criteria: 1) Acute kidney injury or renal function impairment caused by other reasons (recent rapid decline in renal function, or kidney damage caused by drugs, infections, etc.); 2) Other primary or secondary kidney diseases (such as systemic lupus erythematosus, polycystic kidney disease, etc.); 3) Uncontrolled severe complications (such as severe cardiovascular disease, uncontrolled hypertension, severe infections, etc.); 4) Critical organ failure (severe diseases of the heart, liver, or lungs); 5) Pregnancy or planned pregnancy (women currently pregnant or planning to become pregnant during the study); 6) Drug allergy or clear contraindications (allergic to the study drug or its components); 7) Non-cooperative or unable to follow the study protocol (unable or unwilling to comply with study requirements); 8) Abnormal coagulation function, or undergoing anticoagulant therapy (such as warfarin, rivaroxaban, etc.) with bleeding risk; 9) Currently taking Chinese herbal medicine or patent Chinese medicine with effects of tonifying deficiency, promoting blood circulation, or dispelling wind-dampness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine albumin-to-creatinine ratio;24-hour urinary protein;Urinary albumin excretion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete or partial remission at weeks 12, 24, and 36;Adverse event; | — |
Countries
China
Contacts
Hangzhou Hospital of Traditional Chinese Medicine