Diabetes Kidney Disease
Conditions
Interventions
Control Group:Basic treatment plus empagliflozin (Manufacturer: Boehringer Ingelheim Pharma GmbH & CO.KG
Approval Number: National Medical Product Administration Approval No. HJ20201008), specification: 10 mg per tablet, administered orally, 1 tablet once daily.
Treatment Group:The control group’s treatment regimen plus Jianpi Yishen Qinghua Heluo Decoction (ingredients: Radix Astragali 30 g, Rhizoma Polygonati 15 g, Rhizoma Dioscoreae 15 g, Fructus Corni 15
the liquid from the two decoctions is combined, and taken warmly in two portions, once in the morning and once in the evening.
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
24 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-80 years old, regardless of gender; 2.Meeting the diagnostic criteria for DKD (Diabetic Kidney Disease) Stage G1-G3a and A2-A3; 3.Non-dialysis patients with stable disease conditions; 4.TCM (Traditional Chinese Medicine) syndrome differentiation belonging to spleen-kidney qi deficiency syndrome and dampness-heat stasis syndrome; 5.Blood pressure: systolic blood pressure = 70 mmHg; 6.No mental illnesses, clear consciousness, and having the ability of independent judgment; 7.Having not participated in clinical trials of other drugs within 3 months before being enrolled in the study; 8.Understanding the entire process of the trial, voluntarily accepting treatment, and signing the Informed Consent Form. Note: All the above criteria must be met for a patient to be enrolled in the study.
Exclusion criteria
Exclusion criteria: 1.Patients with proteinuria caused by diabetes mellitus (DM) complicated with non-diabetic renal diseases (NDKD) (including primary kidney diseases or other secondary kidney diseases except diabetic kidney disease (DKD)); 2.Patients with kidney diseases caused by type 1 diabetes mellitus, gestational diabetes mellitus, or secondary diabetes mellitus; 3.Patients who have experienced acute complications of diabetes mellitus (e.g., diabetic ketoacidosis) within 1 month prior to screening, or have had stress conditions such as surgery or trauma; 4.Patients with severe primary diseases or complications involving the cardiovascular system, cerebrovascular system, respiratory system, liver, hematopoietic system, or other systems; 5.Patients with consumptive diseases such as malignant tumors and tuberculosis, as well as other acute or chronic infectious diseases; 6.Patients with urinary system infections; 7.Patients with massive proteinuria (24-hour urinary protein quantification > 3.5 g); 8.Patients who are allergic or intolerant to any component of the drugs used in this study; 9.Patients who have used nephrotoxic drugs (e.g. non-steroidal anti-inflammatory drugs, iodine contrast agents) within 3 months prior to screening; 10.Patients who have newly used angiotensin II receptor blockers (ARB) or angiotensin-converting enzyme inhibitors (ACEI) within 3 months prior to screening; 11.Patients who are pregnant, lactating, or planning to become pregnant in the near future. Note: Patients who meet any one of the above criteria shall be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary albumin-creatinine ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimated glomerular filtration rate; | — |
Countries
China
Contacts
Public ContactGao Jiandong
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed