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- Title
Chinese herbal medicine Tangshen Formula treatment of patients with type 2 diabetic kidney disease with macroalbuminuria: study protocol for a randomized controlled trial.
- Authors
Meihua Yan; Yumin Wen; Liping Yang; Xi'ai Wu; Xiaoguang Lu; Bingxuan Zhang; Weiping Huang; Ping Li; Yan, Meihua; Wen, Yumin; Yang, Liping; Wu, Xi'ai; Lu, Xiaoguang; Zhang, Bingxuan; Huang, Weiping; Li, Ping
- Abstract
<bold>Background: </bold>Diabetic 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.<bold>Methods/design: </bold>This 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.<bold>Discussion: </bold>This study will provide evidence for the effectiveness and safety of TSF compared to placebo in treating DKD patients with macroalbuminuria.<bold>Trial Registration: </bold>Chinese Clinical Trials Registry, ChiCTR-TRC-13003566 . Registered 9 August 2013.
- Subjects
CHINA; KIDNEY diseases; HERBAL medicine; ALBUMINURIA; RANDOMIZED controlled trials; GLOMERULAR filtration rate; PROTEINURIA; TYPE 2 diabetes diagnosis; TYPE 2 diabetes complications; COMPARATIVE studies; CREATININE; DIABETIC nephropathies; EXPERIMENTAL design; KIDNEYS; RESEARCH methodology; MEDICAL cooperation; RESEARCH protocols; CHINESE medicine; RESEARCH; TIME; EVALUATION research; TREATMENT effectiveness; BLIND experiment; DIAGNOSIS
- Publication
Trials, 2016, Vol 17, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-016-1385-2