NCT01182025

Brief Summary

The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 17, 2010

Status Verified

August 1, 2010

Enrollment Period

11 months

First QC Date

August 13, 2010

Last Update Submit

August 16, 2010

Conditions

Hand, Foot and Mouth Disease

Keywords

Mild type of hand, foot and mouth diseaseXiyanping InjectionEffectivenessSafety

Outcome Measures

Primary Outcomes (2)

  • time of bringing down the fever

    Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.

    10 days

  • time of body temperature going back to normal

    Refering to the time of the armpit temperature of lower than 37.0 degrees Celsius, lasting for at least 24 hours, after the medicine is taken.

    10 days

Secondary Outcomes (5)

  • time of symptom disappearance

    10 days

  • case severity rate

    10 days

  • time of tetter disappearance

    10 days

  • direct medical cost

    10 days

  • safety outcome

    10 days

Study Arms (3)

Western therapy

ACTIVE COMPARATOR
Other: Western therapy

Xiyanping Injection

EXPERIMENTAL
Drug: Xiyanping Injection

Xiyanping Injection with western medicine

EXPERIMENTAL
Drug: Xiyanping Injection with western medicine

Interventions

Western therapyOTHER

Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care. 1. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius; 2. Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;

Western therapy
Xiyanping InjectionDRUG

Dosage for child medication: 5-10mg/kg/d (0.2-0.4ml/kg/d) in 5% Glucose solution, IV, with speed of 20-30 drops per minute, each day; or as directed by doctor.

Xiyanping Injection
Xiyanping Injection with western medicineDRUG

1. Symptomatic treatment using the same treatment methods in western therapy group; 2. Symptomatic treatment using the same treatment methods in Xiyanpin injection group.

Xiyanping Injection with western medicine

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination.
  • Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes.
  • Age of 1-14 years.
  • Patients or their guardians agree to participate in this study and signed the informed consent form.

You may not qualify if:

  • Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
  • With history of allergies on traditional Chinese medicine.
  • Patients or their guardians suffering from Psychiatric diseases.
  • Attending other clinical studies on HFMD after diagnosed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Affiliated Hospital of Guilin Medical College

Guilin, Guangxi, 541001, China

RECRUITING

Liuzhou Worker's Hospital

Liuchow, Guangxi, 541001, China

RECRUITING

Liuzhou People's Hospital

Liuchow, Guangxi, 545001, China

RECRUITING

Shenzhen Maternity & Child Healthcare Hospital

Shenzhen, Guangzhou, 518028, China

RECRUITING

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, 330006, China

RECRUITING

MeSH Terms

Conditions

Hand, Foot and Mouth DiseaseMouth Diseases

Condition Hierarchy (Ancestors)

Coxsackievirus InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsStomatognathic Diseases

Study Officials

  • Guoliang Zhang

    An'Hui Chinese Medical College Affiliated No.1 Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2010

First Posted

August 16, 2010

Study Start

June 1, 2010

Primary Completion

May 1, 2011

Study Completion

December 1, 2011

Last Updated

August 17, 2010

Record last verified: 2010-08

Locations

CN(5)