Clinical Trial: Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect and Safety of Xiao'er Jiebiao Oral Liquid in Combination With Standard Treatment on Hand-foot-mouth Disease in Pediatric Patients

Brief Summary: This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth disease compared with the controlgroup that recieve only libavirin treatment.

Detailed Summary:
Sponsor: Children's Hospital of Fudan University

Current Primary Outcome:

  • Time (hours) taken from treatment start till body temperature dropping to normal [ Time Frame: time length( hours) from treatment starting to the time that body temperature drop to normal 37.0 degree for 12 hours ]
  • Time (hours) taken from disease onset till body temperature dropping to normal [ Time Frame: time length (hours) from the disease onset (the starting of fever) till the time that body temperature dropped to normal (37.0 degree) and lasting for at least 12 hours ]
  • Top body temperature at the 24th hour, 48th hour and the 72th hour from treatment starting. [ Time Frame: from starting of treatment to the 24th hour, 48th hour, and the 72th hour ]
    top body temperature at 3 time points after treatment diarrhea


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • adverse digestive tract symptoms [ Time Frame: from start of treatment to discharge ]
    proportion of patients with digestive tract symptoms during treatment, such as vomit, abdomial pain or diarrhea
  • abnormal blood routine [ Time Frame: from the start of treatment to discharge test ]
    defined as 1 if any abnormal blood routine occur, otherwise defined as 0
  • abnormal Urine routine [ Time Frame: from the start of treatment to discharge ]
    defined as 1 if any liver function examination or kidney function examination occur, otherwise defined as 0


Original Secondary Outcome: Same as current

Information By: Children's Hospital of Fudan University

Dates:
Date Received: December 18, 2014
Date Started: October 2014
Date Completion:
Last Updated: February 4, 2016
Last Verified: February 2016