Diabetic Kidney Disease
Conditions
Interventions
Control group:Standard treatment
Test group:Yiqi Yangyin Xiaozheng Tongluo prescription with syndrome differentiation and flavoring+Standard treatment
Sponsors
Dongzhimen Hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1: Between the ages of 18 and 80; 2: Meets the diagnostic criteria for DKD. 3: Patients at high risk of DKD progression:15=eGFR<60mL/(min·1.73m2) 4: Traditional Chinese medicine syndrome types are determined as patients with kidney deficiency and collateral stasis syndrome, kidney deficiency and collateral stasis syndrome combined with internal heat syndrome, or kidney deficiency and collateral stasis syndrome combined with dampness and turbidity syndrome; 5: Fully understand the research purpose and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1: Patients with primary glomerular disease, occult nephritis, autoimmune diseases and connective tissue diseases, hematological diseases, tumors, drug-induced renal damage, and bilateral renal artery stenosis who have been clearly diagnosed; 2: 24-hour urine protein quantification>3.5g/24h 3: Patients with acute complications of diabetes such as diabetes ketoacidosis, hyperosmolar hyperglycemic coma within 6 months; 4: Patients with severe primary diseases such as respiratory, digestive, and hematological disorders, as well as heart failure with reduced ejection fraction (LVEF = 40%). Patients currently experiencing severe infections, trauma, major surgeries, acute coronary syndrome, acute heart failure, uncontrolled malignant arrhythmias, and other emergency stress states; 5: Pregnant, breastfeeding, and those with fertility plans; 6: Patients with active hepatitis and impaired liver function (alanine aminotransferase and aspartate aminotransferase are more than twice the normal upper limit); 7: Type 1 diabetes and special type diabetes; 8: Poor blood pressure control: systolic blood pressure = 160mmHg and/or diastolic blood pressure = 100mmHg, or hypotension: systolic blood pressure8mmol/L; 10: The serum potassium concentration exceeds the upper limit of normal values in the laboratory of the research unit; 11: Patients with unstable basic treatment for lowering blood sugar and blood lipids within the past 3 months (changing medication types, such as replacing beta blockers with calcium ion blockers); 12: Started taking within the past 2 weeks: a. Other drugs for DKD (fenelione, GLP-1 drugs, etc.), b. calcium dobesilate for diabetes retinopathy, c. traditional Chinese patent medicines and simple preparations, Chinese herbal decoction, formula granule and other Chinese herbal preparations with the same ingredients or functions, d. Tripterygium wilfordii related preparations, Huangkui capsules, Keluoxin capsules, etc; 13: Patients who have been using anticoagulants with stable dosages for less than one month. 14: When clinical researchers believe that participants in clinical studies cannot cooperate with observation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proteinuria related events;Progress incidence rate;Renal composite endpoint event; | — |
Secondary
| Measure | Time frame |
|---|---|
| GFR slope;Blood lipids;Renal function;Blood glucose;Traditional Chinese Medicine Syndrome Points; | — |
Countries
China
Contacts
Public ContactHongfang Liu
Dongzhimen Hospital of Beijing University of Chinese Medicine
Outcome results
None listed