Efficacy and Safety of Keluoxin Capsule in the Treatment of Diabetic Kidney Disease

Abstract Background: Diabetic kidney disease (DKD), which is a serious complication of diabetes and the leading cause of end-stage renal disease, becomes a major health concern worldwide. Keluoxin capsule, a Chinese patent medicine used for DKD, has been widely used in diabetic kidney disease, but its efficacy and safety have not yet been clarified. Therefore, the aim of this systematic review and meta-analysis is to summarize the efficacy and safety of Keluoxin capsule in the treatment of DKD. Methods: A systematic literature search will be conducted in PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure, WANFANG database, VIP, SinoMED, and Chinese Biomedical Literature Database (CBM) to ensure all possible randomized controlled trials (RCT) studies on K eluoxin capsule to November 1, 2021. The primary outcome to be assessed will include the change in albuminuria and estimated glomerular filtration rate (eGFR), while secondary outcomes will be serum creatinine, blood urea nitrogen, glycated hemoglobin, total cholesterol, low-density lipoprotein cholesterol, and triglycerides, etc and adverse events. The quality of the included studies and the risk of bias will be independently assessed by two reviewers using the risk of bias assessment tool from Cochrane Handbook. We will conduct random-effects model meta-analysis using Review Manager software (Revman5.3). Discussion: This systematic review and meta-analysis will objectively evaluate the effect of Keluoxin capsule for DKD, and provide evidence for Keluoxin capsule in the treatment of DKD. Ethics and dissemination : Ethics approval is not required for this study. We aim to publish the results of this systematic review in a peer-reviewed journal. INPLASY registration number: INPLASY 2021110067.