Abstract
Background
Diabetic kidney disease (DKD) is a serious complication associated with diabetes mellitus and can cause end-stage renal disease (ESRD). Traditional Chinese medicine (TCM) is widely used in China to treat DKD, and in particular microalbuminuria and macroalbuminuria. This study will address the efficacy and safety of Shenzhuo Formula (SZF), a frequently prescribed TCM, in DKD patients with macroalbuminuria.
Methods/design
This study is a 24-week, randomized, multi-center, double-blinded, double-dummy, controlled, clinical trial that will include 120 DKD patients aged 18 to 80 years old with a 24-h urinary protein (24-h UP) level of between 0.5 g and 3 g and serum creatinine (SCr) ≤ 133 μmol/L (1.5 mg/dL) and compare SZF to irbesartan. The 24-h UP change from baseline to week 24 will represent the primary endpoint with secondary endpoints including SCr, estimated glomerular filtration rate (eGFR), TCM symptoms, urinary albumin excretion rate (UAER), etc. Safety assessments will also be evaluated.
Discussion
This study will provide initial evidence regarding the efficacy and safety of SZF relative to irbesartan in the treatment of DKD patients with macroalbuminuria.
Trial registration
Chinese Clinical Trial Registry, ID: ChiCTR-ICR-15006311. Registered on 15 April 2015.
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Details
1 Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (GRID:grid.464297.a); Beijing University of Chinese Medicine, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176)
2 Beijing University of Chinese Medicine, Center for Evidence-based Chinese Medicine, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176)
3 Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (GRID:grid.464297.a)
4 Hepingli Hospital, Beijing, China (GRID:grid.464297.a)
5 South area of Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (GRID:grid.410318.f) (ISNI:0000 0004 0632 3409)
6 Beijing University of Chinese Medicine, Dongzhimen Hospital, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176)
7 Zouping County Hospital of TCM, Binzhou, China (GRID:grid.24695.3c)
8 Yongzhou Central Hospital, Yongzhou, China (GRID:grid.24695.3c)