Diabetic kidney disease
Conditions
Interventions
Experimental Group:Conventional intervention + Shenzhuo Formula
Control Group:Conventional intervention + Placebo
Sponsors
Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Meet the Western medical diagnostic criteria for diabetic kidney disease (DKD)./2Be aged between 18 and 75 years old. 2.Have an estimated glomerular filtration rate (eGFR) of 25 = eGFR < 75 ml/(min·1.73m²). 3.Have a urinary albumin - creatinine ratio (UACR) of 30< UACR = 5000 mg/g. 4.Meet the traditional Chinese medical diagnostic criteria for Qi deficiency and collateral stasis syndrome. 5.Have received treatment with the maximum tolerated dose of angiotensin - converting enzyme inhibitors (ACEI) or angiotensin II 6.receptor blockers (ARB) for at least 4 weeks before randomization. 7.Sign the informed consent form
Exclusion criteria
Exclusion criteria: 1.Currently receiving other Chinese herbal medicines or patent Chinese medicines with therapeutic effects on DKD or with a washout period 12%. 6.AST/ALT > 3×ULN or total bilirubin > 2×ULN at screening. 7.Symptomatic hypotension (systolic blood pressure 170 mmHg or diastolic > 100 mmHg); or NYHA class IV heart failure. 8.Hospitalization for stroke transient ischemic attack acute coronary syndrome or decompensated heart failure within 4 weeks prior to screening; underwent PCI/CABG/valve repair/replacement within 4 weeks prior to screening or planned for any of these procedures post-randomization. 9.Any other condition/treatment rendering participants unsuitable for the study with inability to complete the entire planned study period (e.g. active malignancy life expectancy < 12 months). 10.Currently pregnant breastfeeding planning pregnancy or fertile women not using effective contraception; participants who enrolled in other drug clinical trials within 1 month prior to this trial or are currently participating in other trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal Composite Endpoint Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to First Occurrence of Cardiac Composite Endpoint;Change from baseline in glomerular filtration rate (GFR);Change from baseline in Urinary Albumin-Creatinine Ratio;KDQOL-36/EQ-5D-5L Quality of Life Scale;Traditional Chinese Medicine (TCM) Symptoms and Syndrome Scoring Scale; | — |
Countries
China
Contacts
Public ContactDu Qingfeng
Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed