Chinese herbal medicine Tangshen Formula treatment of patients with type 2 diabetic kidney disease with macroalbuminuria: study protocol for a randomized controlled trial

Abstract

BackgroundDiabetic kidney disease (DKD) is one of the most common microvascular complications of diabetes mellitus and the main cause of end-stage renal disease. Present medications for DKD are not entirely satisfactory. Preliminary studies indicate that the Chinese herbal formula Tangshen Formula (TSF) appears to decrease the proteinuria and improve the estimated glomerular filtration rate (eGFR) in DKD patients.Methods/designThis trial is a five-center, randomized, double-blind, placebo-controlled study. DKD patients with a 24-h urinary protein (24 h UP) level between 0.5 and 3.5 g and serum creatinine < 265 μmol/L (3 mg/dl) will be included. A sample size of 144 participants will be randomly distributed into the treatment group (TSF plus irbesartan) and the control group (placebo plus irbesartan) at a ratio of 1:1. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The primary endpoint will be the 24 h UP. Secondary endpoints will be an evaluation of renal function, management of blood lipids, improvement in traditional Chinese medicine symptoms, and safety assessments. Adverse events will also be evaluated.DiscussionThis study will provide evidence for the effectiveness and safety of TSF compared to placebo in treating DKD patients with macroalbuminuria.Trial registrationChinese Clinical Trials Registry, ChiCTR-TRC-13003566. Registered 9 August 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1385-2) contains supplementary material, which is available to authorized users.

ErHuang Formula Improves Renal Fibrosis in Diabetic Nephropathy Rats by Inhibiting CXCL6/JAK/STAT3 Signaling Pathway

“…Traditional Chinese Medicine (TCM) has been used for thousands of years for the treatment of a variety of disorders (Wen et al, 2017). This has led to clinical observations which have provided evidence of safety and efficacy of TCM usage including its use in the treatment of DN (Yan et al, 2016;Zhao et al, 2018).…”

DMP-1 attenuates oxidative stress and inhibits TGF-β activation in rats with diabetic kidney disease

“…Many clinical experiences have showed that Chinese herbal compound prescription can protect patients’ kidneys from DKD injury with various and complex mechanisms. 29–31 In our study, we also found that DMP-1 had protective effects on DKD in rats induced by STZ-injection, which was demonstrated as following criteria: 1) a significant reduction in levels of urea ( p < 0.05), BUN ( p < 0.05), UCr ( p < 0.05), β2-MG ( p < 0.05) and mALB ( p < 0.05) in rats treated by DMP-1 compared with STZ group; 2) an apparent increment levels of NOS ( p < 0.05), CAT ( p < 0.05) and T-AOC ( p < 0.05), while reduction in level of MDA ( p < 0.05) in DMP-1 groups compared with STZ group; 3) a significant inhibition of TGF-β and Smad2/3 overexpression in kidney tissue. And DMP-1 could increase Smad7 expression as well; 4) rats in DMP-1 medium dose group whose dosage were equal to the clinical dose had the best kidney protected effect among the three DMP-1 groups.…”

Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease with Qi and Yin Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

“…This study will be a trial of a new therapeutic regimen of KLX treatment. The sample size was calculated using software PASS based on a similar study on a Chinese herbal medicinal supplement conducted previously [15]. Allowing for a 20% withdrawal rate, we plan to include 126 patients in this trial.…”