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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Xuebijing injection in the treatment of severe pneumonia: study protocol for a randomized controlled trial

Authors: Ping Wang, Yuanlin Song, Zhi Liu, Hui Wang, Wenke Zheng, Si Liu, Zhiqiao Feng, Jingbo Zhai, Chen Yao, Ming Ren, Chunxue Bai, Hongcai Shang

Published in: Trials | Issue 1/2016

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Abstract

Background

Severe pneumonia (SP) is a major complication of respiratory system diseases that is associated with high mortality and morbidity. If not treated correctly, it may rapidly lead to sepsis and multiple organ dysfunction syndrome. Despite continuous developments in antibiotic treatments for SP, the mortality rate remains high. Both basic and clinical research show that Xuebijing injection (XBJ) can improve the symptoms of SP. The aim of this study is to evaluate the effectiveness and safety of XBJ compared with placebo.

Methods/design

This multicenter, blinded, randomized controlled trial will be conducted with a total of 700 participants with SP. Using a central randomization system, participants will be randomized (1:1) into groups receiving either XBJ or placebo (within 24 h of diagnosis of SP) for 5–7 days with a 28-day follow-up. All participants will receive conventional treatment simultaneously. Both XBJ and placebo will be administered using a photophobic infusion set to avoid bias. The primary outcome is improvement of Pneumonia Severity Index risk rate. Adverse events will be monitored throughout the trial.

Discussion

This is the first and largest randomized trial done in China on SP treatment using a Chinese herbal extract. In this trial, we will use central randomization and an electronic case report form, and we have designed an innovative blinding method for the traditional Chinese medicine injection. The results of this trial may help to provide evidence-based recommendations to clinicians for treatment of SP.

Trial registration

Chinese Clinical Trials Registry ChiCTR-TRC-13003534. Registered 24 June 2013.
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Metadata
Title
Xuebijing injection in the treatment of severe pneumonia: study protocol for a randomized controlled trial
Authors
Ping Wang
Yuanlin Song
Zhi Liu
Hui Wang
Wenke Zheng
Si Liu
Zhiqiao Feng
Jingbo Zhai
Chen Yao
Ming Ren
Chunxue Bai
Hongcai Shang
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1282-8

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