Diabetes nephropathy
Conditions
Interventions
Experimental group:Qibang Tangshen Formula
Control group:placebo
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) It meets the clinical diagnostic criteria of diabetes nephropathy; 2) Age = 18 years old and = 80 years old, regardless of gender; 3) Patients with type 2 diabetes should take hypoglycemic drugs or insulin regularly for half a year or more, with HbA1C = 8% (refer to KDIGO guidelines in 2020); 4) UACR = 30mg/g or UAER = 30mg/24h; ALB = 25g/L; 5) EGFR (using CKD-EPI formula): 25~60 ml. min-1. (1.73m2) -1); 6) Routine use of ARB drugs (such as valsartan 80mg/day, etc.) for at least one month; Before randomization, blood pressure was controlled at: systolic blood pressure<160 mmHg, diastolic blood pressure<100 mmHg; 7) Voluntarily sign an informed consent form before the start of activities related to this study, and be able to understand the procedures and methods of this study. Willing to strictly follow the clinical research protocol to complete this study.
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes patients; 2) Patients with abnormal liver function test results (AST, ALT, or alkaline phosphatase>3 times ULN), or other known acute or chronic active hepatitis or cirrhosis; 3) Has a history of recurrent hypoglycemia in the past; 4) Those who use steroids or immunosuppressants due to kidney disease or kidney transplantation; 5) Suffering from other chronic kidney diseases during screening (such as chronic glomerulonephritis, chronic pyelonephritis, ischemic kidney disease, etc.); 6) Patients with recurrent urinary tract infections or genital fungal infections prior to screening; 7) Screening for individuals with blood pressure consistently above 180/100mmHg in the first two weeks; 8) Individuals with blood potassium levels>5.5 mmol/L during screening; 9) Within 6 months before screening, patients with severe acute diabetes complications (ketoacidosis, lactic acidosis, hypertonic non ketotic diabetes coma, hypoglycemic coma) occurred; 10) Screening patients who have developed acute coronary syndrome, heart failure (NYHA score III-IV) within the first 3 months, or have undergone surgical treatment for heart related diseases, stroke, or poor prognosis after stroke; 11) Individuals with a history of mental illness or language barriers before screening who are unable or unwilling to cooperate; 12) Prior to screening, there was a history of autoimmune diseases (such as systemic lupus erythematosus); 13) Screening for individuals diagnosed with a history of malignant tumor disease within the first six months; 14) HIV patients; 15) Individuals who are allergic to experimental drugs; 16) Individuals who are currently participating in clinical trials of other drugs or have participated in trials of other drugs within the past 3 months prior to screening (referring to those who have been enrolled and received treatment with investigational drugs); 17) Pregnancy plans, pregnant or lactating female patients within six months; 18) Other situations that the researcher deems unsuitable for conducting this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eGFR; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event incidence rate; | — |
Countries
China
Contacts
Public ContactLin Wang
Longhua Hospital affiliated Shanghai University of Traditional Chinese Medicine
Outcome results
None listed