Trial | NCT02328651  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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 Started
Oct 31
2014
Primary Completion
Apr 30
2018
Study Completion
May 31
2018
Last Update
Aug 07
2018

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）

Ribavirin treatment plus testing drug Experimental

Ribavirin treatment Active Comparator

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.
No Results Posted