Chronic Kidney Disease
Conditions
Interventions
Experimental group:Shenkefu capsule
Control group:Shenkefu capsule simulator
Sponsors
Affiliated hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for primary glomerular diseases; 2. Diagnosis of CKD stage 3b-4 (15<=eGFR[ml/min.1.73m2)]<45); 3. 24h urine protein quantification <=3g; 4. According to syndrome differentiation of TCM it belongs to Damp-heat and blood stasis toxin; 5. Male or female 18-70 years of age; 6. Voluntary participation in this clinical trial, informed consent and signing of informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary chronic kidney diseases (such as diabetic nephropathy, lupus nephritis, drug-induced nephropathy, kidney transplantation, etc.); 2. Acute kidney injury has occurred in the past month; 3. Blood pressure >=140/90mmhg or blood uric acid >=500umol/l; 4. Combined with diabetes, acute infectious diseases, chronic hepatitis B active phase and persistent phase, liver cirrhosis decompensation phase, active tuberculosis, mental disorder or psychosis; 5. Glucocorticoid, immunosuppressants, or renal replacement therapy have been used in the past 3 months or are currently required for treatment; 6. The combination of other diseases requires long-term treatment (>=4 weeks) with traditional Chinese medicine (proprietary Chinese medicines, formula granules, decoction, etc.); 7. At the end of the run-in period, eGFR decreased by >=25% (CKD-EPI formula was adopted) compared with that before run-in (screening); 8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of the normal reference value; 9. Combined with serious primary diseases such as cardiovascular and cerebrovascular diseases, lung diseases, liver diseases, central nervous system diseases, hemopoietic system diseases, etc.; 10. Suspect or have a history of alcohol and drug abuse; 11. Women in Pregnancy or lactation or pregnancy plans within six months; 12. Known or suspected allergy to test drugs and their excipients; 13. participated in other clinical trials in the past 3 months; 14. Researchers think it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| estimated glomerular filtration rate (eGFR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Creatinine (SCR);Blood Urea Nitrogen (BUN);Blood Uric Acid (UA);24-hour urinary protein quantification; Albumin-to-creatinine ratio (ACR);24-hour urine volume;hemoglobin (HB);Red Blood Cells (RBC);inflammatory indexes (TNF-alpha, IL-6, HS-CRP);Blood Lipids; Fasting Blood Glucose;TCM Syndrome;Kidney Disease Quality of Life Short Form (KDQOL-SF) ;End-point events (eGFR decrease >=25% from baseline; 24h urine protein = 3.5g; Disease progression to G5; For renal replacement therapy); Immunoreactive Parathyroid Hormone (iPTH) ; | — |
Countries
China
Contacts
Public ContactMingquan Li
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed