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

NCT02328651 | Completed Phase 4

• 1 other identifier: XEJB_Ver1.0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Handfoot-mouth Disease

Keywords

Mild and Moderate Severe Patients With hand_foot-mouth Disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• adverse digestive tract symptoms

  from start of treatment to discharge

• abnormal blood routine

  from the start of treatment to discharge test

• abnormal Urine routine

  from the start of treatment to discharge

Study Arms (2)

Ribavirin treatment plus testing drug

EXPERIMENTAL

Drug: Ribavirin plus Xiao'er jiebiao oral liquid

Ribavirin treatment

ACTIVE COMPARATOR

Drug: Ribavirin

Interventions

Ribavirin plus Xiao'er jiebiao oral liquid 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 plus testing drug

Ribavirin 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）

Ribavirin treatment

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• with history of any heart, lung, kidney or liver diseases; under any hormonotherapy, immunoglobulin therapy or any other therapy.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Weihai Rensheng Pharmacy: collaborator

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 31, 2014
• Study Start: October 1, 2014
• Primary Completion: April 30, 2018
• Study Completion: May 31, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

CN (1)