Diabetic Kidney Disease
Conditions
Interventions
Treatment Group:Tangshen Tongluo Formula(TSTL) plus usual care
Sponsors
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. All patients met the diagnostic criteria for diabetic kidney disease (DKD) according to the 2021 Chinese Guidelines for the Prevention and Treatment of Diabetic Kidney Disease, with an estimated glomerular filtration rate (eGFR) > 45 mL·min-1·(1.73 m²)-1 and a urinary albumin-to-creatinine ratio (UACR) of 30 mg/g < UACR = 300 mg/g. 2. Patients met the syndrome differentiation criteria for 'spleen–kidney qi deficiency syndrome' of diabetic kidney disease as defined in the Diagnostic, Syndrome Differentiation, and Efficacy Evaluation Criteria for Diabetic Kidney Disease (Trial Version, 2007). 3. Age between 18 and 75 years. Patients and their family members were fully informed about the study, voluntarily agreed to participate, signed written informed consent, and were able to cooperate with and complete the study procedures.
Exclusion criteria
Exclusion criteria: 1.Non–type 2 diabetes mellitus (T2DM) patients; 2.Pregnant or lactating women; patients with severe cardiac, hepatic, or renal impairment; and individuals with psychiatric or intellectual disorders; 3.Patients with chronic kidney disease caused by other etiologies; 4.Participation in other clinical trials within 4 weeks prior to the start of treatment; 5.Patients with psychiatric disorders; 6.Known or suspected allergy to the investigational drug or any of its components; 7.Patients with diabetic kidney disease who have already undergone renal replacement therapy; 8.Patients unable to complete the treatment protocol as scheduled; 9.Recent participation in other clinical trials; 10.History of drug abuse; 11.Patients with comorbid conditions that may interfere with the study medication or affect the study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine albumin-to-creatinine ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Symptom Score;Urinary microalbumin;serum creatinine;Estimated glomerular filtration rate;Uric acid;Blood urea nitrogen;Fasting plasma glucose;Hemoglobin A1c; | — |
Countries
China
Contacts
Public ContactMa Li
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Outcome results
None listed