title: [Andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome: a multicenter and randomized controlled trial].
abstract: OBJECTIVE
  To evaluate the safety and efficacy of andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome.
  
  
  METHODS
  A multicenter, randomized controlled trial was conducted. In phase I, 202 patients with acute upper respiratory tract infection were randomly divided into two groups: trial group (n=101) and control group (n=101). In phase II, 276 patients with acute upper respiratory tract infection were randomly divided into two groups: trial group (n=138) and control group (n=138). The patients in the trial group received andrographolide drop-pill, at a dose of 1.5 g, three times a day; the patients in the control group received andrographolide tablet, at a dose of 1.5 g, three times a day. The therapeutic courses in both groups were 3 days. Clinical symptoms, physical signs, adverse effects, blood, urine and stool tests, hepatorenal function and electrocardiogram were examined before and after the treatment.
  
  
  RESULTS
  After treatment in the phase I, the cure rates in the trial group and the control group were 44.55%, 42.57% (full analysis set, FAS) and 45.00%, 43.00% (per protocol set, PPS), and the total obvious rates were 94.06%, 94.06% (FAS) and 95.00%, 95.00% (PPS), respectively. There were no significant differences between the two groups (P>0.05). In the phase II, the cure rates in the trial group and the control group were 39.13%, 33.82% (FAS) and 38.69%, 33.58% (PPS), and the total obvious rates were 96.38%, 96.32% (FAS) and 96.36%, 96.27% (PPS), respectively. There were no significant differences between the two groups (P>0.05) too. No adverse effects were found in the trial.
  
  
  CONCLUSIONS
  Andrographolide drop-pill is effective and safe in the treatment of acute upper respiratory tract infection with external wind-heat syndrome.
authors.affiliation: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Chang
authors.forename: Rui-ming
authors.initials: RM
authors.lastname: Zhang
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhang
authors.forename: Zhi-bin
authors.initials: ZB
authors.lastname: Chen
authors.forename: Zong-ming
authors.initials: ZM
authors.lastname: Zhang
authors.forename: Qiang
authors.initials: Q
authors.lastname: Xu
authors.forename: Yu-ping
authors.initials: YP
authors.lastname: Yang
authors.forename: You-yu
authors.initials: YY
authors.lastname: Long
authors.forename: Liang-li
authors.initials: LL
authors.lastname: Liu
authors.forename: Hong-yan
authors.initials: HY
authors.lastname: Cai
authors.forename: Jie
authors.initials: J
authors.lastname: Gao
authors.forename: Nan
authors.initials: N
authors.lastname: Lu
authors.forename: Bing
authors.initials: B
authors.lastname: Mao
authors.forename: Lei
authors.initials: L
authors.lastname: Wang
authors.forename: Ting-qian
authors.initials: TQ
authors.lastname: Li
mesh_terms: D000328:Adult; D003937:Diagnosis, Differential; D004224:Diterpenes / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D004224:Diterpenes; D013607:Tablets; C030419:andrographolide