Diabetic Kidney Disease (DKD)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 18-75, any gender 2) Confirmed diagnosis of type 2 diabetes with HbA1c =11% at screening 3) Meet DKD diagnostic criteria: eGFR (CKD-EPI) 25-75 mL/min/1.73m² with UACR =30 mg/g, or eGFR 25-3 months) 4) TCM pattern of Qi-Yin deficiency with blood stasis 5) Willing to sign informed consent and comply with follow-up
Exclusion criteria
Exclusion criteria: 1 Severe diabetic complications (e.g., ketoacidosis, hyperosmolar coma) or recent (=6 months) acute cardiovascular events (MI, unstable angina, stroke) 2) Active infections within 4 weeks 3) Current or recent (=4 weeks) use of other herbal treatments for DKD 4) Pregnancy, planned pregnancy, or lactation 5) Known allergy to Tangshen Formula components 6) Severe comorbidities: hematologic disorders, malignancies, NYHA Class III-IV heart failure, liver dysfunction (ALT/AST >2×ULN) 7) Uncontrolled hypertension (resting SBP =160 mmHg and/or DBP =100 mmHg) 8) Psychiatric disorders affecting compliance 9) Non-diabetic kidney disease (e.g., glomerulonephritis) 10) Hyperkalemia (serum K+ >5.5 mmol/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated Glomerular Filtration Rate (eGFR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary albumin-to-creatinine ratio;glycosylated hemoglobin; | — |
Countries
China
Contacts
China-Japan Friendship Hospital