The Efficacy of Xiaoyu Xiezhuo Decoction on Chronic Kidney Disease in Stage 3-4: a Multicenter Clinical Study
- Conditions
- Chronic Kidney Disease
- Registration Number
- ITMCTR2200006734
- Lead Sponsor
- Zhejiang Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Patients who meet the diagnostic criteria of ckd3-4 of Western medicine;
(2) Meet the TCM standards for qi deficiency and stasis;
(3) Patients aged 18-75 years old, without gender limitation, and who have not received dialysis treatment;
(4) Blood pressure = 140 / 90mmHg after basic hypotension;
(5) The primary diseases are chronic glomerulonephritis, hypertension, diabetes, hepatitis B Related Nephritis and so on, and the disease is stable;
(6) The patient agreed to the treatment of the study, joined the chronic disease management, and signed the informed consent;
(7) No other drug tests have been conducted in the last 3 months or the effective drug elution period has passed
(1) Patients with acute infectious diseases and surgical and traumatic stress;
(2) Patients with chronic infectious diseases, such as chronic hepatitis B in the active phase and delayed migration, cirrhosis in the decompensated phase or active tuberculosis;
(3) Diseases with severe organ function damage affecting the survival of patients, such as malignant tumors and HIV infection;
(4) Patients with serious primary diseases such as cardiovascular, blood system, digestive system and respiratory system;
(5) Those who have a history of major bleeding or blood transfusion in the past 3 months, have signs of serious clinical infection and acidosis, complicated with hyperkalemia, heart failure and other life-threatening patients;
(6) Severe allergic constitution, allergic or intolerable to certain drugs known in the study;
(7) Pregnant or lactating patients;
(8) Have a history of drug abuse;
(9) Patients with primary polycystic kidney disease;
(10) Patients who are participating in other clinical trials or who use other traditional Chinese medicine in the same period to affect the judgment of efficacy;
(11) The fluctuation range of eGFR within 3 months before enrollment was = 30%;
(12) Those who are ready for or have adopted renal transplantation, and those who have acute renal failure, chronic renal failure with acute exacerbation and need immediate replacement treatment;
(13) Acute renal injury caused by post renal factors, such as obstruction (including renal calculi, urate crystals, tumors, etc.);
(14) Patients with a history of psychosis or communication and cognitive impairment who have poor compliance and cannot cooperate.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method serum creatinine;
- Secondary Outcome Measures
Name Time Method protein-creatinine ratio;estimated glomerular filtration rate;