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Bailing Capsule combined with α-ketoacid tablets for stage 3 chronic kidney disease: Protocol of a double-blinded,
Xiuhong Hu1, Jing Wang, Hongjuan Yang
1The First Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China.
Insights
This study investigates if Bailing Capsule (BC) combined with compound α-ketoacid tablets (KA) can improve symptoms and kidney function in stage 3 chronic kidney disease (CKD) patients. The trial is a double-blinded, randomized, controlled study over 8 weeks.
Area of Science:
- Nephrology
- Pharmacology
- Clinical Trials
Background:
- Chronic kidney disease (CKD) is a progressive condition with increased risks after stage 3.
- Compound α-ketoacid tablets (KA) are used for CKD adjunctive therapy with protein restriction.
- Bailing Capsule (BC) is a Chinese medicine that may improve renal function and reduce kidney damage.
Purpose of the Study:
- To evaluate the efficacy and safety of Bailing Capsule (BC) combined with compound α-ketoacid tablets (KA) in treating stage 3 CKD.
- To assess the impact of the combined therapy on patient-reported symptoms and clinical markers of kidney function.
Main Methods:
- A double-blinded, randomized, controlled trial with 1:1 allocation to treatment (BC + KA) or control (BC-simulation + KA) groups.
- An 8-week treatment course monitoring subjective symptoms, Patient Global Assessment (PGA), serum creatinine, cystatin C, and estimated glomerular filtration rate (eGFR).
- Adverse events, vital signs, and physical examinations were recorded; data analyzed using SPSS 21.0.
Main Results:
- The study is designed to collect data on symptom changes and kidney function markers.
- Analysis will focus on improvements in fatigue, anorexia, halitosis, nausea, itching, and edema.
- Changes in serum creatinine, cystatin C, and eGFR will be compared between groups.
Conclusions:
- The results will determine if BC combined with KA can alleviate symptoms in stage 3 CKD patients.
- The study aims to establish the effectiveness of this combination therapy for improving kidney function.
- This trial will provide evidence on the safety and efficacy of BC and KA for CKD management.
Background:
Chronic kidney disease (CKD) is a progressive and irreversible loss of kidney function. After stage 3, there will be increased risks of hypertension, heart failure, bone disease, anemia, gastrointestinal symptoms, and progression to end-stage kidney failure without proper intervention and treatment. Compound α-ketoacid tablets (KA) administration plays an important role in clinical CKD adjunctive therapy for patients with restricted protein intake. Bailing Capsule (BC), a commonly used Chinese patent medicine for renal diseases, could regulate human immune function, repair renal tubular epithelial cells, prevent renal tubular atrophy, and reduce kidney damage to improve renal function. In this study, we try to conduct a double-blinded, randomized, controlled trial to observe the efficacy and safety of BC combined with KA in treating patients with stage 3 CKD.
Methods:
This is a double-blinded, randomized, controlled trial. Patients will be randomly divided into treatment group (BC and KT) and control group (BC-simulation and KT) in a 1:1 ratio according to random number table. The treatment course will be 8 weeks, and the changes of subjective symptoms, patient global assessment (PGA) scale, serum creatinine, cystatin C, and estimated glomerular filtration rate, all related adverse events, vital sign measurements, and physical examinations will be recorded. SPSS 21.0 will be used for data analysis.
Conclusions:
The results will show whether BC combined with KA could alleviate the symptoms of fatigue, anorexia, halitosis, nausea, itching, and edema, improve kidney function in patients with CKD at stage 3.
Trial Registration:
OSF Registration number: DOI 10.17605/OSF.IO/24AJ7.
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