A multi-center, randomized, controlled, double-blind clinical study on the treatment of Chronic kidney disease with Kidney-Yang deficiency syndrome by Wenshenyang prescriptio
- Conditions
- Chronic kidney disease
- Registration Number
- ITMCTR2100004410
- Lead Sponsor
- Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Volunteer to participate in the clinical trial and sign the informed consent;
2. Subjects meeting the diagnostic criteria of chronic kidney disease;
3. Patients with nephrotic syndrome, chronic nephritis syndrome, diabetic nephropathy, IgA nephropathy, membranous nephropathy, focal segmental sclerosing glomerulonephritis, etc;
4. EGFR > 29ml / (min · 1.73m2) in patients with chronic kidney disease (CKD) stage 1-3;
5. Patients with kidney yang deficiency syndrome in TCM;
6. Patients aged 18-75 years old, regardless of gender.
1. Patients with acute kidney injury in recent one month;
2. Patients with acute infectious diseases, active or delayed chronic hepatitis B, decompensated cirrhosis and active tuberculosis;
3. Patients with serious cardiovascular and cerebrovascular diseases, lung and liver diseases and other primary diseases, or mental diseases;
4. Patients with unstable vital signs and severe electrolyte disorder, or have received renal replacement therapy;
5. Patients with active gastrointestinal bleeding, severe thrombocytopenia, coagulation dysfunction and other hematological diseases in recent 3 months;
6. Patients with other diseases requiring long-term use of other traditional Chinese medicine preparations for more than 4 weeks;
7. Those patients whose aspartate aminotransferase and alanine aminotransferase are 1.5 times higher than the normal value;
8. Pregnant women, lactating women or women with pregnancy plans in the near future;
9. Those subjects with allergic constitution are known or suspected to be allergic to the test drug and its excipients;
10. Subjects who have participated in or are participating in other clinical trials in recent 3 months;
11. Subjects considered unsuitable by the researchers to participate in this clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Twenty-four hours urinary protein content;urine albumin-creatinine ratio;TCM syndrome Rating Scale;Glomerular filtration rate;Serum creatinine;
- Secondary Outcome Measures
Name Time Method albumin;Blood uric acid;hemoglobin;total protein;Blood urea nitrogen;