title: Xuebijing injection in the treatment of severe pneumonia: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Chinese Clinical Trials Registry ChiCTR-TRC-13003534 . Registered 24 June 2013.
authors.affiliation: Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin, 300193, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Wang
authors.affiliation: Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University, Shanghai Institute of Respiratory Medicine, Shanghai, 200032, China.
authors.forename: Yuanlin
authors.initials: Y
authors.lastname: Song
authors.affiliation: Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin, 300193, China.
authors.forename: Zhi
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin, 300193, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Wang
authors.affiliation: Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin, 300193, China.
authors.forename: Wenke
authors.initials: W
authors.lastname: Zheng
authors.affiliation: Tianjin Chase Sun Pharmaceutical Co. Ltd, 20 Quanfa Road, Tianjin Wuqing Development Area, Tianjin, 300170, China.
authors.forename: Si
authors.initials: S
authors.lastname: Liu
authors.affiliation: Tianjin Chase Sun Pharmaceutical Co. Ltd, 20 Quanfa Road, Tianjin Wuqing Development Area, Tianjin, 300170, China.
authors.forename: Zhiqiao
authors.initials: Z
authors.lastname: Feng
authors.affiliation: Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin, 300193, China.
authors.forename: Jingbo
authors.initials: J
authors.lastname: Zhai
authors.affiliation: Peking University Clinical Research Institute, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
authors.forename: Chen
authors.initials: C
authors.lastname: Yao
authors.affiliation: Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin, 300193, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Ren
authors.affiliation: Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University, Shanghai Institute of Respiratory Medicine, Shanghai, 200032, China.
authors.forename: Chunxue
authors.initials: C
authors.lastname: Bai
authors.affiliation: Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin, 300193, China. shanghongcai@foxmail.com.|Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Haiyuncang Lane, Dongcheng District, Beijing, 100700, China. shanghongcai@foxmail.com.
authors.forename: Hongcai
authors.initials: H
authors.lastname: Shang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002681:China; D002985:Clinical Protocols; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000175:diagnosis / Q000188:drug therapy*; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; C549376:Xuebijing
keywords: Blinding; Randomized controlled trial; Safety; Severe pneumonia; Xuebijing injection