title: Simultaneous use of traditional Chinese medicine (si-ni-tang) to treat septic shock patients: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Even though there are continually upgraded recommendations for managing sepsis, such as "Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock", mortality is still high. Si-ni-tang, a remedy documented in Shanghan Lun, a medical collection from ancient China, is used for treating patients with sepsis and septic shock. Using a well-designed clinical trial, we are eager to survey the effectiveness of the concurrent use of this remedy in restoring these patients' hemodynamic status, or "Yang Qi".
  
  
  METHODS
  Patients admitted to our medical intensive care units with the diagnosis of septic shock, defined as persistent hypotension induced by sepsis despite adequate fluid resuscitation, are eligible for participation. The inclusion criteria include: age from 20 to 85 years, conditions meeting the definition of septic shock, use of vasopressors within 24 hours of entering the study, and use of a nasogastric tube for feeding. The enrolled patients are randomly allocated either to the si-ni-tang group or the placebo group. The prescription of the trial drugs (si-ni-tang/placebo) is 2.25 grams 4 times a day for 7 days or till shock reversal (if shock reversal occurs in less than 7 days). Data, including duration of vasopressor infusion, gender, age, co-morbidities, APACHE II score, predicted mortality, ICU mortality, ICU length of stay, hospital mortality, hospital length of stay, source of sepsis, and culture results, are collected for the following analysis.
  
  
  CONCLUSIONS
  Si-ni-tang is composed of processed Zingiber officinale, Glycyrrhiza uralensis, and Aconitum carmichaeli. Zingiber officinale and Glycyrrhiza uralensis are found to have the ability to reduce pro-inflammatory cytokine production, to inhibit lipopolisaccharide-induced macrophage activation and function, and to lessen the bacterial load and suppress acute and chronic inflammation. Aconitum carmichaeli is known to have vasopressor activity, and positive chronotropic and inotropic effects. As this remedy has a potential benefit in treating septic shock patients, we designed a double-blind, prospective, randomized controlled trial and would like to publish the results and conclusions later.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01223430.
authors.affiliation: Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan.
authors.forename: Huang-Chi
authors.initials: HC
authors.lastname: Chen
authors.forename: Wen-Chi
authors.initials: WC
authors.lastname: Chen
authors.forename: Kai-Huang
authors.initials: KH
authors.lastname: Lin
authors.forename: Yung-Hsiang
authors.initials: YH
authors.lastname: Chen
authors.forename: Lun-Chien
authors.initials: LC
authors.lastname: Lo
authors.forename: Tsung-Chieh
authors.initials: TC
authors.lastname: Lee
authors.forename: Te-Chun
authors.initials: TC
authors.lastname: Hsia
authors.forename: Chu-Hsien
authors.initials: CH
authors.lastname: Wang
authors.forename: Shin-Hwar
authors.initials: SH
authors.lastname: Wu
authors.forename: Hsin-Whae
authors.initials: HW
authors.lastname: Hsu
authors.forename: Yu-Jun
authors.initials: YJ
authors.lastname: Chang
authors.forename: Yu-Chuen
authors.initials: YC
authors.lastname: Huang
authors.forename: Tien-Hsiung
authors.initials: TH
authors.lastname: Ku
authors.forename: Ming-Hwarng
authors.initials: MH
authors.lastname: Horng
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002681:China; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D012772:Shock, Septic / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; C478756:sini tang