Diabetic Kidney Disease
Conditions
Interventions
Experimental Group:On the basis of conventional Western medical treatment, Shenshu Fjian Decoction was additionally administered for an 8-week intervention.
Control Group:Conventional Western medical treatment (blood glucose control, blood pressure management, protein intake restriction, etc., as part of symptomatic treatment) for an 8-week intervention p
Healthy Reference Group:None
Sponsors
Bishan Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for DKD cases: (1) Meeting the diagnostic criteria for diabetic kidney disease, with traditional Chinese medicine (TCM) syndrome differentiation of kidney deficiency and blood stasis complicated with turbidity; (2) Aged between 18 and 80 years; (3) Voluntary participation in this study and provision of signed informed consent. Inclusion criteria for the Healthy Reference Group: (1) aged between 18-80 years; (2) good physical condition in the past with stable vital signs; (3) voluntarily participating in this study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for DKD Cases: (1) Women who are planning pregnancy, pregnant, or lactating. (2) Patients with primary or secondary renal diseases not caused by diabetes. (3) Patients with severe primary diseases of the heart, lung, liver, brain, or other vital organs. (4) Presence of psychiatric or psychological disorders that are uncontrolled or require ongoing counseling, which may affect study compliance. (5) Use of corticosteroids, immunosuppressants, probiotics, or antibiotics within the past 3 months. (6) Known allergy or hypersensitivity to any component of the investigational drug. (7) Heavy smoking or alcohol consumption that is difficult to control. (8) Severe hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN). (9) Poor compliance, failure to adhere to prescribed medication, or inability to complete the treatment course. (10) Estimated glomerular filtration rate (eGFR) 3500 mg/24 h. (11) Patients with end-stage DKD on dialysis. Exclusion Criteria for the Healthy Reference Group: (1) Women who are pregnant or menstruating. (2) Presence of chronic diseases such as diabetes, hypertension, or kidney disease. (3) Recent significant abnormalities in complete blood count, urinalysis, stool routine test, liver function, renal function, or electrocardiogram. (4) Use of probiotics or antibiotics within the past 3 months. (5) Heavy smoking or alcohol consumption that is difficult to control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine albumin excretion rate (UAER);Urine albumin-to-creatinine ratio (UACR);estimated Glomerular Filtration Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| creatinine;Fasting Blood Glucose;glycated hemoglobin;Triglyceride;Total Cholesterol;TCM Syndrome Score;36-Item Short Form Health Survey (SF-36) score;Pittsburgh Sleep Quality Index (PSQI) global score;Gut Microbiota Metagenomic Testing;Metabolomics analysis; | — |
Countries
China
Contacts
Public ContactXiaoren Tang
Bishan Hospital of Chongqing Medical University
Outcome results
None listed