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.

Medicine
|May 20, 2021
PubMed

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.
Abstract

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