Diabetic kidney disease
Conditions
Interventions
TQF group:Tangshen Qushi Formula (TQF) plus conventional Western medical treatment
Placebo group:Placebo plus conventional Western medical treatment
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Adult patients meeting the Western diagnostic criteria for DKD: clear history of diabetes with a causal relationship to urinary protein and renal function changes, and exclusion of other primary or secondary glomerular diseases and systemic disorders. Must fulfill at least one of the following: 1) Random urinary albumin-to-creatinine ratio (UACR) = 30 mg/g or urinary albumin excretion rate (UAER) = 30 mg/24h, with UACR or UAER confirmed in 2 out of 3 repeated tests within 3–6 months above the threshold, after excluding confounding factors such as infection. 2) eGFR < 60 ml/min/1.73m² for more than 3 months. 3) Renal biopsy consistent with DKD pathological changes. (2) TCM pattern diagnosis consistent with one or more types of dampness pattern (diagnostic criteria refer to the 2017 DKD Syndrome Differentiation and Efficacy Evaluation Guidelines issued by the World Federation of Chinese Medicine Societies Diabetes Professional Committee). (3) eGFR 25–89.9 mL/min/1.73m², with fluctuation within = 30% in the 3 months prior to enrollment. (4) Urine protein-to-creatinine ratio (UPCR) = 3.5 g/g. (5) All enrolled patients must provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients requiring immediate dialysis; those receiving corticosteroid or immunosuppressive therapy; patients with active malignant tumors; severe arrhythmia or severe heart failure (NYHA class III or above); pregnant or breastfeeding women; patients unable to cooperate (e.g., psychiatric illness); patients currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eGFR slope (the annual decline rate of glomerular filtration rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary albumin-to-creatinine ratio;Urinary protein-to-creatinine ratio;Renal function set (serum creatinine blood urea nitrogen serum uric acid serum albumin);Fasting blood glucose;HbA1c%;Blood lipids profile (triglycerides cholesterol high- and low-density lipoprotein cholesterol);Survival analysis of the incidence of composite renal endpoint events;Assessment of manifestations of dampness syndrome in traditional Chinese medicine; | — |
Countries
China
Contacts
Public ContactXusheng Liu
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed