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

Handfoot-mouth Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328651
• Other study ID #: XEJB_Ver1.0
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: May 31, 2018

Study information

• Verified date: August 2018
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Handfoot-mouth Disease
• Mouth Diseases

Intervention

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 ?treatment for control symptoms ? 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 ?treatment for control symptoms ? 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.?anti-intracranial pressure treatment: mannitol 2~5ml/kg,iv, Bid~tid)
• Ribavirin
For mild (PhaseI) patients : recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ?treatment for control symptoms ? 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 ?treatment for control symptoms ? 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.?anti-intracranial pressure treatment: mannitol 2~5ml/kg, iv, Bid~tid)

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Weihai Rensheng Pharmacy

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (hours) taken from treatment start till body temperature dropping to normal		time length( hours) from treatment starting to the time that body temperature drop to normal 37.0 degree for 12 hours
Primary	Time (hours) taken from disease onset till body temperature dropping to normal		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
Primary	Top body temperature at the 24th hour, 48th hour and the 72th hour from treatment starting.	top body temperature at 3 time points after treatment diarrhea	from starting of treatment to the 24th hour, 48th hour, and the 72th hour
Secondary	adverse digestive tract symptoms	proportion of patients with digestive tract symptoms during treatment, such as vomit, abdomial pain or diarrhea	from start of treatment to discharge
Secondary	abnormal blood routine	defined as 1 if any abnormal blood routine occur, otherwise defined as 0	from the start of treatment to discharge test
Secondary	abnormal Urine routine	defined as 1 if any liver function examination or kidney function examination occur, otherwise defined as 0	from the start of treatment to discharge