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

August 5, 2018 updated by: Hui Yu, Children's Hospital of Fudan University

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ribavirin treatment plus testing drug

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

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
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
from starting of treatment to the 24th hour, 48th hour, and the 72th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from start of treatment to discharge
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
from the start of treatment to discharge test
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
from the start of treatment to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 5, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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