Chinese herbal medicine Tangshen Formula Treatment For Type 2 Diabetic Kidney Disease in Early Stage : study protocol for a randomized controlled trial

Abstract

Background: Diabetic kidney disease (DKD) is the main cause of end stage kidney disease (ESKD) and It has become a heavy economic and social burden due to its high prevalence and morbidity. The most effective strategy is that patients with DKD should be diagnosed and treated early. Preliminary studies showed the Chinese herbal Tangshen Formula (TSF) may delay the progression of DKD, reducing micro-and macro-albuminuria and improving renal function. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of TSF in patients with DKD. Methods/design: This trial is a thirteen-center, randomized, double-blind, placebo-controlled study. 623 participants will be randomized in a 1:1 ratio to an experiment group (TSF plus Losartan) and a control group (placebo plus Losartan). The trial cycle will last 24 weeks. The primary outcome will be the change in Urine microalbumin creatinine ratio （ ACR ） from baseline to week 24. The secondary outcome will be the change in the rate of progression into the clinical proteinuria period after intervention, the rate of urine microalbumin negative conversion, the rate of normal urinary microalbumin, doubling rate of baseline creatinine value and glomerular filtration rate (GFR) between the two groups. Safety in medication will also be evaluated. Discussion: We hypothesize that type 2 diabetic patients in early stage of DKD will benefit from TSF. If successful, this study will provide evidence-based recommendations for clinicians. Trial registration: ClinicalTrials.gov (NCT03009864) Keywords: Diabetes Kidney Disease, Traditional Chinese medicine, Treatment, Randomized controlled trial