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

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ClinicalTrials.gov Identifier: NCT02328651
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Weihai Rensheng Pharmacy
Information provided by (Responsible Party):
Hui Yu, Children's Hospital of Fudan University

Tracking Information
First Submitted Date  ICMJE December 18, 2014
First Posted Date  ICMJE December 31, 2014
Last Update Posted Date August 7, 2018
Study Start Date  ICMJE October 2014
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
  • 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Handfoot-mouth Disease
Intervention  ICMJE
  • Drug: Ribavirin plus Xiao'er jiebiao oral liquid

    For mild (Phase I) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d( diluted in 100ml 5%GS),qd, ivgg, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.

    For moderate (Phase II) patients:

    recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d( diluted in 100ml 5%GS),qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2~5ml/kg,iv, Bid~tid)

  • Drug: Ribavirin

    For mild (PhaseI) patients : recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d( diluted in 100ml 5%GS),qd, intravenous drip.

    For moderate (PhaseII) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d( diluted in 100ml 5%GS),qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2~5ml/kg, iv, Bid~tid)

Study Arms  ICMJE
  • Experimental: Ribavirin treatment plus testing drug
    Intervention: Drug: Ribavirin plus Xiao'er jiebiao oral liquid
  • Active Comparator: Ribavirin treatment
    Intervention: Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2014)
398
Actual Study Completion Date  ICMJE May 31, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:subjects should meet all of the following

  • diagnosed as hand-foot-mouth disease grade I or grade II;
  • body temperature at admission T>38℃,fever length<48 hours;
  • no need for hormonotherapy or immunoglobulin therapy.
  • signed written informed consent form

Exclusion Criteria:subjects should be excluded if meet any of the following

  • with history of any heart, lung, kidney or liver diseases; under any hormonotherapy, immunoglobulin therapy or any other therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02328651
Other Study ID Numbers  ICMJE XEJB_Ver1.0
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hui Yu, Children's Hospital of Fudan University
Study Sponsor  ICMJE Children's Hospital of Fudan University
Collaborators  ICMJE Weihai Rensheng Pharmacy
Investigators  ICMJE Not Provided
PRS Account Children's Hospital of Fudan University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP