Efficacy and Safety Evaluation of the Traditional Chinese Medicine Treatment 'Fu Pi Shen, Hua Yu Shi' in Delaying the Progression of Chronic Renal Failure
- Conditions
- Chronic kidney disease (CKD)
- Registration Number
- ITMCTR2023000066
- Lead Sponsor
- Chongqing Traditional Chinese Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1) Patients diagnosed with chronic kidney disease.
2) Age = 18 years to = 75 years, both genders.
3) CKD stage 3-5, with renal function eGFR > 15 to = 60 ml/min/1.73m2 (calculated using the CKD-EPI equation), and no need for blood purification treatment.
4) Signed informed consent form.
1) Abnormal liver function (ALT, AST greater than 2.5 times the upper limit of normal).
2) Patients with a recent history (within three months) of severe cardiovascular diseases such as myocardial infarction, coronary artery bypass grafting, or ischemic heart disease with heart failure (functional class III-IV, NYHA classification).
3) Patients with a recent history (within three months) of severe cerebrovascular diseases such as stroke, or significant neurological functional impairment after stroke.
4) Patients with a recent history (within three months) of active gastrointestinal bleeding.
5) Known severe thrombocytopenia (PLT < 10x109/L) or abnormal coagulation function.
6) Persistent elevation of blood potassium level > 5.5mmol/L.
7) History of allergy to the components of the investigational drug.
8) Pregnant or lactating women.
9) Patients scheduled for urgent hemodialysis treatment.
10) Currently using corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive agents.
11) Other diseases or conditions, as determined by the investigator, that may reduce the likelihood of enrollment or complicate the study, such as mental illness, frequent changes in living and working environment leading to loss to follow-up.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite Endpoints:GFR is not decreased, with an increase of less than 10%; blood creatinine is not increased, or decreased by less than 10%; all-cause mortality;
- Secondary Outcome Measures
Name Time Method Changes in traditional Chinese medicine syndrome efficacy score;Kidney function;