Effect of Recombinant Human Interferon α-2b Spray on Herpangina

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

668 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-12-31

Brief Summary

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This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric patients with herpangina.

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Detailed Description

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Conditions

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Herpangina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Recombinant Human Interferon α-2b Spray

Group Type EXPERIMENTAL

Recombinant Human Interferon α-2b Spray

Intervention Type DRUG

Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour).

Ribavirin

Group Type ACTIVE_COMPARATOR

Ribavirin

Intervention Type DRUG

Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ).

Interventions

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Recombinant Human Interferon α-2b Spray

Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour).

Intervention Type DRUG

Ribavirin

Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Subjects should meet all of the following:

1. meet the diagnostic criteria for pediatric herpangina;
2. ages 1-7 years, no limitation for gender;
3. within 72 hours of onset;
4. the main organs (heart, liver, kidney and lung) function normally;
5. follow up according to requirements and be hospitalized for observation;
6. the guardian is fully informed and signed informed consent.

Exclusion Criteria

Subjects should be excluded if meet any of the following:

1. have allergy history of interferon;
2. heart failure, respiratory insufficiency,liver and kidney dysfunction or severe malnutrition and other serious disease, or immunodeficient;
3. children with epilepsy or other neurological disorders;
4. other pathogens exist at the same time;
5. the researchers believe that it is not appropriate to participate in this study.

Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No