Diabetic Kidney Disease
Conditions
Interventions
Shenzhuo Formula Group:Shenzhuo Formula
Placebo Group:Placebo
Sponsors
Guang'anmen Hospital of the China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for type 2 diabetic kidney disease 2.Age 18-75 years old; 3.Meet one of the following: (i) eGFR =30ml/(min1.73m2), <60ml/(min1.73m2); (ii) eGFR =60 ml/(min1.73m2), <90 ml/(min1.73m2), and UACR= 200mg/g; 4.Meet the diagnostic criteria for qi deficiency and blood stasis pattern based on traditional Chinese medicine; 5.HbA1c =10%; 6.Blood pressure =140/90mmHg; 7.Informed consent of the subject and signature on the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Currently receiving other Chinese medicines or Chinese patent medicines that have therapeutic effects on DKD; 2. Combined with other kidney diseases, such as glomerulonephritis, hypertensive kidney damage, kidney tumors, drug-induced kidney damage, etc.; 3. Patients with a history of recurrent urinary and reproductive system infections; 4. Combined with severe cardiovascular, liver, kidney, immune system diseases or psychiatric diseases; 5. Allergic to Chinese herbal ingredients; 6. ALT and AST exceeded 2.5 times the upper limit of normal at enrollment; 7. Currently pregnant, lactating, or women with pregnancy plans; 8. Patients with type 1 diabetes; 9. Known eGFR fluctuations of more than 30% in the past three months; 10. Patients who have participated in other drug clinical trials in the past month or are currently participating in other clinical trials; 11. Other conditions or situations as determined by the investigator that may reduce enrollment possibilities or complicate enrollment, such as frequently changing work environments, unstable living environments, etc. that are likely to cause loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in eGFR from the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| urinary albumin-to-creatinine ratio;Traditional Chinese Medicine Symptom Score;Quality of Life Scale Score;eGFR monthly change rate;percentage of patients with eGFR decline over 30%; | — |
Countries
China
Contacts
Public ContactLinhua Zhao
Guang'anmen Hospital of the China Academy of Chinese Medical Sciences
Outcome results
None listed