Abstract
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. However, the current therapies for DKD are not entirely perfect. 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, improving renal function. This trial was conducted to assess the effectiveness and safety of TSF used in combination with conventional treatment.
Methods/design: We are implementing a randomized, placebo-controlled, multicenter, clinical trial as a means of evaluating the effectiveness and safety of TSF. 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 lasts 24 weeks. The primary outcome will be changes in ACR from baseline to 24 weeks between the two groups and ACR will be compared at baseline and treatment endpoint in each group. The secondary outcome will be changes in the ratio of progression into the clinical proteinuria period after intervention, Urine micro albumin negative conversion rate, the ratio of normal urinary micro albumin, doubling rate of baseline creatinine value and 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 an evidence-based complementary remedies for delaying the progression of DKD.
Trial registration: ClinicalTrials.gov (NCT03009864)
Keywords: Diabetes Kidney Disease, Traditional Chinese medicine, Treatment, Clinical trials，Randomized controlled trial
Efficacy and Safety of Tangshen Formula on Patients with Type 2 Diabetic Kidney Disease: A Multicenter Double-Blinded Randomized Placebo-Controlled Trial
