Diabetic Nephropathy
Conditions
Interventions
Experimental Group:Zhixiao Yishen Wan + Western Medicine Standardized Treatment
Control Group:Chinese herbal placebo + Western Medicine Standardized Treatment
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients with a clear clinical diagnosis of DKD and meeting the early-stage criteria established by this study, with eGFR = 60 ml/min/1.73m²; 2) Age between 18 and 75 years; 3) Blood pressure < 140/90 mmHg (systolic blood pressure < 150 mmHg for individuals over 60 years old) and glycated hemoglobin < 9% after the run-in period treatment; 4) Chinese medicine syndrome of internal heat; 5) No restriction on gender.
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis considers non-diabetic kidney disease (non-DKD) (sudden severe deterioration of renal function, abrupt increase in proteinuria, accompanied by active urinary sediment, without diabetic retinopathy, etc.);2. Severe infection, severe anemia, electrolyte disorders, or other complications occurred within the past 4 weeks;3.Acute kidney injury, oliguria or anuria, severe edema, massive pleural effusion, or ascites;4.History of use of glucocorticoids, immunosuppressants, or Tripterygium wilfordii formulations within the past 12 weeks;5.Use of antibiotics, probiotics, prebiotics, or laxatives within the past month prior to enrollment;6.Gastrointestinal symptoms such as nausea, vomiting, diarrhea, or abdominal pain within the past month prior to enrollment;7.Severe diseases of the heart, brain, liver, or hematopoietic system (cerebral infarction, cerebral hemorrhage, transient ischemic attack, myocardial infarction, unstable angina pectoris, heart failure, alanine aminotransferase elevated to more than 3 times the upper limit of normal) within the past 3 months prior to enrollment, or history of glucocorticoid or immunosuppressive use;8.History of tuberculosis or other wasting diseases, or history of mental disorders;9.Pregnant women, women planning pregnancy, or breastfeeding women;10.History of allergy to the investigational drug or its components;11. History of suspected or confirmed alcohol or substance abuse;12.Currently participating in other interventional clinical trials or having participated in other clinical trials within the past 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine microalbumin/creatinine ratio(UACR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose;Postprandial Blood Glucose;glycated hemoglobin;Estimated glomerular filtration rate(eGFR);24-hour urinary protein quantification;Albumin;Triglyceride;Low-Density Lipoprotein;TCM Syndrome Score;Short Form Health Survey(SF-36); | — |
Countries
China
Contacts
Public ContactWang Zhen
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed