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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

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.

Condition or disease Intervention/treatment Phase
Handfoot-mouth Disease Drug: Ribavirin plus Xiao'er jiebiao oral liquid Drug: Ribavirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect and Safety of Xiao'er Jiebiao Oral Liquid in Combination With Standard Treatment on Hand-foot-mouth Disease in Pediatric Patients
Study Start Date : October 2014
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: Ribavirin treatment plus testing drug 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)


Active Comparator: Ribavirin treatment 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)





Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328651


Locations
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China
Children's Hospital of Fudan University
Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Weihai Rensheng Pharmacy

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Responsible Party: Hui Yu, Professor, Director, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02328651     History of Changes
Other Study ID Numbers: XEJB_Ver1.0
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

Keywords provided by Hui Yu, Children's Hospital of Fudan University:
Mild and Moderate Severe Patients With hand_foot-mouth Disease

Additional relevant MeSH terms:
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Mouth Diseases
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Stomatognathic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents