Diabetic Nephropathy
Conditions
Interventions
Experimental Group:On the basis of adequate-dose application of RAS inhibitors, take Yishen Huashi Keli (Kidney-Nourishing and Dampness-Resolving Granules), 10g per sachet, 3 times a day, 1 sachet eac
Control Group:Adequate-Dose Application of RAS Inhibitors in Treatment
Sponsors
Second Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 to 80 years old; Diagnosed with diabetic kidney disease (DKD); Chronic kidney disease (CKD) Stage 1 to 3a (estimated glomerular filtration rate (eGFR) = 45 mL/min/1.73m² calculated by the CKD-EPI formula); 24-hour urinary protein (24h UTP) ranging from 1.0 to 3.0 g; Meeting the diagnostic criteria for TCM syndrome of spleen deficiency with dampness excess: The syndrome can be identified if 2 major symptoms and 2 minor symptoms below are present: Major symptoms: Fatigue and lassitude; poor appetite or loose stools. Minor symptoms: Edema of the face or limbs; soreness and pain of the waist and spine; pale, fat and tender tongue; white or white greasy tongue coating; deep and thready pulse. Having received maximum tolerated and adequate treatment with ACEI or ARB drugs for more than 3 months before the screening visit; Voluntarily participating in the study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: Known allergy to any component of the study drug or history of atopy; Type 1 diabetes mellitus; Complicated with acute diabetic complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome; Systolic blood pressure/diastolic blood pressure higher than 160/100 mmHg after standardized antihypertensive drug treatment; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2 times the upper limit of the normal reference value; Hemoglobin < 90 g/L; Serum albumin < 30 g/L; Complicated with severe diseases of the heart, brain, lungs, liver, hematopoietic system, etc.; Severe infection or active infectious diseases that may affect urinary protein or renal function within 1 month before enrollment; Use of traditional Chinese medicine preparations with similar functions to this study drug within 1 month before enrollment; Use of or current use of systemic glucocorticoids, immunosuppressants, biological targeted drugs, or cytotoxic drugs for the treatment of kidney diseases within 3 months before enrollment; History of organ transplantation; Pregnant or lactating women who cannot take effective contraceptive measures during the study; Participation in other clinical trials within the past 1 month; Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of 24-Hour Urinary Protein Quantitation Decrease from Baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary Albumin-Creatinine Ratio (UACR) and Its Decrease Rate from Baseline;Levels of Serum Creatinine (SCr) and Estimated Glomerular Filtration Rate (eGFR), and Their Decrease Rates from Baseline;Changes in TCM Syndrome Score from Baseline; | — |
Countries
China
Contacts
Public ContactZhou xiaochun
Second Hospital of Lanzhou University
Outcome results
None listed