Diabetic Kidney Disease
Conditions
Interventions
Treatment Group:Keluoxin Capsule+Losartan Potassium
Control Group:Placebo of Keluoxin Capsule + Losartan Potassium
Sponsors
Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Comply with diagnostic criteria for type 2 diabetes and diabetic nephropathy; (2) Comply with diagnostic criteria for Qi and Yin deficiency, blood stasis syndrome; (3) 0.5g/24h=24h urinary protein excretion rate=3.0g/24h; (4) eGFR (CKD-EPI) 30ml/min/1.73m2~59ml/min/1.73m2; (5) Fasting blood glucose<13.9mmol/L and/or 2 hours postprandial blood glucose<16.6mmol/L; (6) HbA1c=10%; (7) Aged between 35 and 75years (inclusive), male or female; (8) Voluntarily participate in this clinical study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Type 1 diabetes; (2) Simple renal hematuria or proteinuria with hematuria, or sudden onset of edema and mass proteinuria without abnormal renal function, or significant renal tubular dysfunction, or combined abnormal renal tubular type, primary glomerulonephritis or secondary nephritis in addition to diabetic nephropathy, or acute and chronic infection of the urinary system; (3) Dosage of losartan potassium tablets at screening>50mg/day; (4) HGB5.5mmol/L (8) Scr=3mg/dL (256µmol/L); (9) In the 3 months prior to screening, there were severe cardiovascular and cerebrovascular diseases: myocardial infarction, or ischemic heart disease undergoing coronary artery bypass or PCI, or congestive heart failure (NYHA grade III or IV), or stroke and significant neurological dysfunction after stroke; (10) Combined with other severe systemic primary diseases and dysfunctions such as liver diseases, hematopoietic system diseases, endocrine system diseases, and respiratory system diseases. Result of ALT or AST is higher than 2.5 times of normal range; (11) Hypertensive patients who take more than 3 kinds of antihypertensive drugs, or who are still poor control after taking antihypertensive drugs with SBP=140mmHg or DBP=90mmHg; Hypotensive patients with SBP=90mmHg or DBP=60mmHg (resting position); (12) Chronic diarrhea, defined as increased frequency of defecation (>3 times/day), increased fecal volume, thin fecal matter, diarrhea more than 3 to 6 weeks or recurrent; (13) Active bleeding in the 3 months prior to screening; (14) Coagulation disorders; (15) Allergic to the study drug and active ingredient of Losartan Potassium Tablets, or allergic constitution, or drug allergies; (16) Having alcohol or drug abuse history or psychiatric disorders history; (17) Pregnancy and lactating women; pregnancy plans (including maternal pregnancy) during the clinical trial; (18) Being enrolled to other clinical study in recent 3 months; (19) There are other circumstances in which the investigator considers it inappropriate to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SCr;eGFR; | — |
Secondary
| Measure | Time frame |
|---|---|
| TC;TG;HDL-C;LDL-C;UTP;UACR;HbA1C;FBG;TCM symptom score; | — |
Countries
China
Contacts
Public ContactWei Jun-ping
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed