- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02328651
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Shanghai, China, 201102
- Children's Hospital of Fudan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ribavirin treatment plus testing 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) |
Active Comparator: Ribavirin treatment
|
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) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time (hours) taken from treatment start till body temperature dropping to normal
Time Frame: time length( hours) from treatment starting to the time that body temperature drop to normal 37.0 degree for 12 hours
|
time length( hours) from treatment starting to the time that body temperature drop to normal 37.0 degree for 12 hours
|
|
Time (hours) taken from disease onset till body temperature dropping to normal
Time Frame: 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
|
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
|
|
Top body temperature at the 24th hour, 48th hour and the 72th hour from treatment starting.
Time Frame: from starting of treatment to the 24th hour, 48th hour, and the 72th hour
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top body temperature at 3 time points after treatment diarrhea
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from starting of treatment to the 24th hour, 48th hour, and the 72th hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse digestive tract symptoms
Time Frame: from start of treatment to discharge
|
proportion of patients with digestive tract symptoms during treatment, such as vomit, abdomial pain or diarrhea
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from start of treatment to discharge
|
abnormal blood routine
Time Frame: from the start of treatment to discharge test
|
defined as 1 if any abnormal blood routine occur, otherwise defined as 0
|
from the start of treatment to discharge test
|
abnormal Urine routine
Time Frame: from the start of treatment to discharge
|
defined as 1 if any liver function examination or kidney function examination occur, otherwise defined as 0
|
from the start of treatment to discharge
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Stomatognathic Diseases
- Enterovirus Infections
- Picornaviridae Infections
- Coxsackievirus Infections
- Mouth Diseases
- Foot-and-Mouth Disease
- Hand, Foot and Mouth Disease
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
Other Study ID Numbers
- XEJB_Ver1.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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