Effect of Qingshen Granules on renal outcome in chronic kidney disease stage 3-4 patients with damp-heat syndrome and safety of Qingshen granules:a real-world multicenter, prospective cohort study
- Conditions
- chronic kidney disease stage 3-4 patients with damp-heat syndrome
- Registration Number
- ITMCTR2100005173
- Lead Sponsor
- the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Aged 18 to 70 years, male or female;
2. Meet the diagnostic criteria of CKD stage 3a-4, as well as the syndrome differentiation criteria of TCM damp-heat syndrome;
3. Blood pressure <140/90mmHg, serum potassium <5.5mmol/L, hemoglobin >=80g/L, infection under control, and stable condition for more than 2 weeks at the time of enrollment;
4. Sign the informed consent.
1. Pregnant or lactating patients;
2. Unable to cooperate, such as mental patients;
3. Combined with serious primary diseases such as active malignant tumor, decompensated liver cirrhosis or hematopoietic system;
4. Patients with infectious diseases;
5. There is acute urinary tract obstructive disease, requiring surgical treatment;
6. Severe arrhythmia, severe heart failure, NYHA class III and above (evidence of New York Heart Association class III and IV), or myocardial infarction or cerebrovascular events within 3 months before enrollment;
7. Are using corticosteroids, non-steroidal anti-inflammatory drugs or immunosuppressants;
8. Those undergoing emergency hemodialysis;
9. Those who have undergone kidney transplantation and total or partial parathyroidectomy;
10. Those who are known to be allergic to or intolerable to a certain drug in this study; patients who are participating in other clinical trials.
Study & Design
- Study Type
- Treatment study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood creatinine doubled;First dialysis;
- Secondary Outcome Measures
Name Time Method Mineral and bone metabolism indexes;Cardiovascular events;Detection of vascular calcification;