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NCT Number: NCT02328651

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

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.

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Key information

Conditions

Handfoot-mouth Disease Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Fudan University

Shanghai, 201102, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ribavirin plus Xiao'er jiebiao oral liquid

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）

Ribavirin

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Weihai Rensheng Pharmacy

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 31, 2014
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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