The Efficacy of Xiaoyu Xiezhuo Decoction on Chronic Kidney Disease in Stage 3-4: a Multicenter Clinical Study
- Conditions
- Chronic Kidney Disease
- Registration Number
- ITMCTR2100004785
- Lead Sponsor
- Zhejiang Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who meet the Western medicine CKD 3-4 diagnostic criteria;
2. Meet the standard of Qi deficiency and blood stasis syndrome in TCM;
3. Those who are 18 to 75 years old, have no gender limit, and have not yet received dialysis treatment;
4. After basic blood pressure reduction, blood pressure <= 140/90mmHg;
5. The blood creatinine (Scr) change within 15% in the past 3 months, hemoglobin (Hb)> 100g/L, no serious acidosis occurred;
6.24h urine protein quantification (24hUpr) <= 2.5g (at least two consecutive determinations, take the average);
7. The primary disease is chronic glomerulonephritis, hypertension, diabetes, hepatitis B-related nephritis, etc., and the condition is stable;
8. The patient agrees to the treatment of this study, joins the chronic disease management, and signs an informed consent form;
9. No other drug test has been performed in the past 3 months or the effective drug wash-out period has passed.
1. Being treated with hormones, non-steroidal anti-inflammatory drugs or immunosuppressive agents;
2. Severe arrhythmia, acute heart failure, myocardial infarction, acute stroke, unstable angina, NYHA classification IV (New York Heart Association Heart Function Classification Standard);
3. Patients with acute infectious diseases, surgery and traumatic stress; patients with chronic infectious diseases such as chronic hepatitis B active and prolonged, decompensated liver cirrhosis, or active tuberculosis;
4. Diseases that are accompanied by severe organ damage that affect the survival of patients, such as malignant tumors, HIV infection, etc.;
5. Patients with severe primary diseases such as cardiovascular, blood system, nervous system, digestive system, respiratory system, etc., and those with obvious bleeding tendency;
6. Complicated with hyperkalemia, heart failure and other life-threatening persons;
7. GFR fluctuation range >= 30% within 3 months before enrollment;
8. Severe allergies, allergic or intolerant to certain drugs known in the study;
9. Patients during pregnancy or lactation;
10. Those who have had a history of hemorrhage or blood transfusion in the past 3 months, and have signs of serious clinical infection or acidosis;
11. Patients who have a history of mental illness or communication and cognitive dysfunction and other poor compliance who cannot cooperate;
12. Non-yellow race.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glomerular filtration rate;
- Secondary Outcome Measures
Name Time Method TCM syndrome integral;serum creatinine;end point events incidence;protein-creatinine ratio;blood urea nitrogen;