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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Handfoot-mouth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ribavirin treatment plus testing drug

Group Type EXPERIMENTAL

Ribavirin plus Xiao'er jiebiao oral liquid

Intervention Type 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 treatment

Group Type ACTIVE_COMPARATOR

Ribavirin

Intervention Type 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）

Interventions

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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）

Intervention Type 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）

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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