Diabetic Nephropathy
Conditions
Interventions
Treatment Group:Mulberry Twig (Sangzhi) Alkaloids
Control group:Jinshuibao Tablets
Sponsors
The Second Clinical Medical College of Jilin University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnostic criteria: Meets the 2025 ADA type 2 diabetes diagnostic criteria and the 2024 KDIGO clinical diagnostic criteria for diabetic nephropathy; 2. At the time of enrollment, FPG was 200ug/min; at the time of enrollment, the renal function was 45ml/min/1.73m² <= eGFR < 60ml/min/1.73m² (using the CKD-EPI formula); 4. If the hypoglycemic regimen is not adjusted within one month, the patient's initial hypoglycemic regimen should be insulin (basal insulin combined with short/rapid-acting insulin, or premixed insulin, with insulin dosage fluctuation <= 20%); 5. Blood pressure should be controlled at <=140/90 mmHg (ACEI/ARB drugs are allowed to be used, but the dosage must be stable for at least 4 weeks); 6. Age: 40 years old or above, gender not restricted; 7. Informed consent: Voluntary participation and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Exclude other kidney diseases: Non-diabetic kidney diseases (such as glomerulonephritis, interstitial nephritis, etc.), or those with kidney damage caused by immune system diseases, renal toxicity, or other diseases; 2. Excluding those who have received kidney replacement therapy, those with severe liver dysfunction (ALT/AST > 3 times ULN), and those who have experienced acute metabolic complications within the last 3 months (such as DKA, HHS); 3. Excluding drug factors: Within the past 3 months, no use of acarbose, SGLT-2 inhibitors, or GLP-1RAs; 4. Excluding those who are allergic to mulberry twig preparations or Jinshuibao, and those who need to use NSAIDs or immunosuppressants for a long time; 5. Excluding those who suffer from severe heart, brain or mental disorders and those who cannot cooperate with the treatment; 6. Excluding special groups: Pregnant or lactating women; Patients with malignant tumors; 7. Exclusion criteria: If the participant has not participated in other clinical trials for less than 3 months, and the investigator determines that there are other factors that may affect the conduct of this study and the interpretation of the research results, then the participant is not eligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary Albumin-to-Creatinine Ratio (UACR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine Routine Test;Interleukin-1ß (IL-1ß);renal function test;tumor necrosis factor-a(TNF-a) ;blood lipid test;glycated hemoglobin (GHB);Blood ion testing;fasting insulin (FINS);Liver function tests;Fasting C-peptide (FCP);fasting blood-glucose (FBG); | — |
Countries
China
Contacts
Public ContactWang Yanjun
The Second Clinical Medical College of Jilin University
Outcome results
None listed