Diabetic kidney disease
Conditions
Interventions
Treatment group:Basic treatment and traditional Chinese medicine decoctions
Control group:Basic treatment
Sponsors
The First Hospital of Tianjin University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. All participants provided written informed consent and agreed to participate in the study. 2. Participants were aged between 18 and 80 years. 3. Participants had a confirmed diagnosis of type 2 diabetic kidney disease at stages G2A3–G4A3, as defined by the "Chinese Guidelines for the Prevention and Treatment of Diabetic Kidney Disease (2021 Edition)." 4. Participants were diagnosed with kidney deficiency accompanied by blood stasis and toxin accumulation according to traditional Chinese medicine (TCM) theory. 5. Estimated glomerular filtration rate (eGFR) was between 25 and 90 mL/min/1.73 m². 6. Urine albumin-to-creatinine ratio (UACR) ranged from 300 to 5000 mg/g; alternatively, 24-hour urinary protein excretion was between 0.5 and 5.0 g/24h. 7. Fasting blood glucose levels were within the range of 4.4–7.7 mmol/L; hemoglobin A1c (HbA1c) was =8.0%; and serum albumin was >25 g/L. 8. Participants had complete clinical records and demonstrated the ability to comply with all study procedures.
Exclusion criteria
Exclusion criteria: : 1. Presence of other severe diabetic complications, such as diabetic ketoacidosis or hyperglycemic hyperosmolar state; 2. Patients with unstable clinical conditions or concomitant severe chronic diseases involving the cardiovascular, cerebrovascular, hepatic, or hematological systems, malignancies, or serious infectious diseases; 3. Patients currently undergoing or who have undergone kidney replacement therapies-including hemodialysis, peritoneal dialysis, hemofiltration, plasma exchange, or kidney transplantation-within the past three months; 4. Patients who have experienced severe local or systemic infections or received antibiotic treatment within the past month; 5. Patients with cognitive or psychiatric conditions that impair their ability to comply with study procedures or provide reliable cooperation; 6. Known presence of severe non-diabetic nephropathy or a recent history of acute renal failure requiring dialysis; 7. Pregnant or breastfeeding women; 8. Baseline blood pressure outside the range of 90/60 mmHg to 160/100 mmHg; 9. Baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels =1.5 times the upper limit of the normal reference range; 10. Participation in any other clinical trial within the past three months or current enrollment in another interventional study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate the slope of the decline in glomerular filtration rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour urine protein quantification;The ratio of urinary albumin to urinary creatinine;Evaluation of TCM syndrome points;The incidence of composite endpoint events in the kidneys; | — |
Countries
China
Contacts
Public ContactJiang Chen
The First Hospital of Tianjin University of TCM
Outcome results
None listed