Efficacy and safety of Shenkang injection in the treatment of chronic renal failure: A protocol of a randomized controlled trial

BACKGROUND: Chronic renal failure (CRF) is the final outcome of the development of multiple kidney diseases, and there is no effective method at home and abroad. Traditional Chinese medicine is found to play a major role in the treatment of the non-replacement stage of CRF. Shenkang injection can not only nourish the kidney, but also promote blood circulation and remove blood stasis, which is suitable for the treatment of CRF. This study aims to explore the efficacy and safety of Shenkang injection for CRF and provide evidence for clinical practice. METHODS: This was a prospective randomized controlled trial. One hundred four patients with CRF were randomly divided into treatment groups and control groups according to 1:1, with 52 patients in each group. The control group received basic treatment of western medicine and the treatment group was given Shenkang injection intravenously on the basis of control group. Both groups were given standard treatment for 4 weeks with concurrent follow-up for 1 month. The outcome indicators included: total efficiency, symptom scores, creatinine clearance rate, serum creatinine, blood urea nitrogen, CystatinC, liver function, blood routine, urine routine, incidence of adverse reactions, etc. Data analysis was performed using SPSS 25.0 software. DISCUSSION: This study will evaluate the efficacy and safety of Shenkang injection for CRF, and the results of this trial will provide clinical evidence for the treatment of CRF. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/K9C5T.