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- 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; Wang, Ping; Song, Yuanlin; Liu, Zhi; Wang, Hui; Zheng, Wenke; Liu, Si; Feng, Zhiqiao; Zhai, Jingbo
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>Chinese Clinical Trials Registry ChiCTR-TRC-13003534 . Registered 24 June 2013.
- Subjects
CHINA; PNEUMONIA diagnosis; COMPARATIVE studies; EXPERIMENTAL design; HERBAL medicine; INTRAVENOUS therapy; RESEARCH methodology; MEDICAL cooperation; RESEARCH protocols; CHINESE medicine; PNEUMONIA; RESEARCH; TIME; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; SEVERITY of illness index; DRUG administration; DRUG dosage
- Publication
Trials, 2016, Vol 17, p142
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-016-1282-8