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

Fudan University

Status and phase: Completed; Phase 4

Conditions: Handfoot-mouth Disease

Treatments: Drug: Ribavirin; Drug: Ribavirin plus Xiao'er jiebiao oral liquid

Study type: Interventional

Funder types: Other

Identifiers

NCT02328651

XEJB_Ver1.0

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Ribavirin treatment plus testing drug

Experimental group

Treatment:

Drug: Ribavirin plus Xiao'er jiebiao oral liquid

Ribavirin treatment

Active Comparator group

Treatment:

Drug: Ribavirin