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01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Trials 1/2016

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

Zeitschrift:
Trials > Ausgabe 1/2016
Autoren:
Meihua Yan, Yumin Wen, Liping Yang, Xi’ai Wu, Xiaoguang Lu, Bingxuan Zhang, Weiping Huang, Ping Li
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-016-1385-2) contains supplementary material, which is available to authorized users.

Abstract

Background

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.

Methods/design

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.

Discussion

This study will provide evidence for the effectiveness and safety of TSF compared to placebo in treating DKD patients with macroalbuminuria.

Trial registration

Chinese Clinical Trials Registry, ChiCTR-TRC-13003566. Registered 9 August 2013.
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