Helping Ease Renal Failure with Shenbing Decoction III Trial: A Randomised Controlled Trial of Shenbing decoction III for Slowing Kidney Failure Progression in Stage 3-5 Chronic Kidney Disease in Non-Dialysis Patients.
- Conditions
- chronic kidney disease 3-5th stage
- Registration Number
- ITMCTR2100005158
- Lead Sponsor
- Southern Medical University Sinowest Medical Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the 2012 KDIGO Chronic Kidney Disease Clinical Practice Guidelines CKD 3-5 diagnostic criteria;
2. The TCM syndrome type conforms to the syndrome differentiation standard of spleen-kidney qi deficiency, turbid toxin and blood stasis;
3. Age 18-70 years old (including 18 years old and 70 years old);
4. Infection, acidosis, electrolyte imbalance, hypertension, etc. are effectively controlled (Bp<140/90mmHg);
5. If ACEI/ARB drugs are used, stable dose treatment is required for more than 2 weeks (inclusive);
6. No treatment with traditional Chinese medicine or proprietary Chinese medicine within 1 month before participating in the clinical trial;
7. The lead-in period is 4 weeks. At the beginning of the lead-in period and the end of the lead-in period, the patients must undergo the following tests respectively. Only those who meet the standards for both test results can enter the test: eGFR<60mL/(min/1.73m2), Bp<140 /90mmHg;
8. The subjects voluntarily signed the informed consent.
1. Coronary heart disease, myocardial infarction, severe arrhythmia, malignant tumor, serious complications such as liver, kidney, hematopoietic system, and severe mental disorders;
2. Acute and chronic nephritis, acute kidney injury, recent history of using nephrotoxic drugs;
3. Patients with renal replacement therapy such as hemodialysis, peritoneal dialysis, and kidney transplantation;
4. Women who are pregnant, planning to become pregnant or breastfeeding;
5. Those who are allergic to the test drug;
6. Those who are participating in clinical trials of other drugs or have participated in other clinical trials within 3 months;
7. The researchers believe that other reasons are not suitable to participate in the clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimated rate of glomerular filtration rate decline;
- Secondary Outcome Measures
Name Time Method Random urine protein-to-creatinine ratio;full segment parathyroid hormone;Urinary kidney injury factor-1;Urinary neutrophil gelatinase-associated lipocalin;Intestinal flora metabolomics;Blood calcium concentration;kidney function(SCR BUN);24-hour urine protein quantification;Hemoglobin;Serum albumin;incidence of endpoint events;Blood phosphorus concentration;Serum transferrin;TCM syndrome score;Prealbumin;Serum ferritin;Erythropoietin;