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A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

Primary Purpose

Hand, Foot and Mouth Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Western therapy
Xiyanping Injection
Xiyanping Injection with western medicine
Sponsored by
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand, Foot and Mouth Disease focused on measuring Mild type of hand, foot and mouth disease, Xiyanping Injection, Effectiveness, Safety

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Affiliated Hospital of Guilin Medical CollegeRecruiting
  • Liuzhou Worker's HospitalRecruiting
  • Liuzhou People's HospitalRecruiting
  • Shenzhen Maternity & Child Healthcare HospitalRecruiting
  • Jiangxi Provincial Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Western therapy

Xiyanping Injection

Xiyanping Injection with western medicine

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

time of symptom disappearance
Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
case severity rate
Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc.
time of tetter disappearance
Refering to the length of time when the tetter due to HFMD disappears, characterised by scab(s) or dropping; and time of oral ulcer concrescence, etc.
direct medical cost
Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
safety outcome
Calculated by adverse event.

Full Information

First Posted
August 13, 2010
Last Updated
August 16, 2010
Sponsor
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Collaborators
Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01182025
Brief Title
A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Collaborators
Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand, Foot and Mouth Disease
Keywords
Mild type of hand, foot and mouth disease, Xiyanping Injection, Effectiveness, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Western therapy
Arm Type
Active Comparator
Arm Title
Xiyanping Injection
Arm Type
Experimental
Arm Title
Xiyanping Injection with western medicine
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Western therapy
Intervention Description
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius; Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;
Intervention Type
Drug
Intervention Name(s)
Xiyanping Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Xiyanping Injection with western medicine
Intervention Description
Symptomatic treatment using the same treatment methods in western therapy group; Symptomatic treatment using the same treatment methods in Xiyanpin injection group.
Primary Outcome Measure Information:
Title
time of bringing down the fever
Description
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
Time Frame
10 days
Title
time of body temperature going back to normal
Description
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.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
time of symptom disappearance
Description
Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
Time Frame
10 days
Title
case severity rate
Description
Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc.
Time Frame
10 days
Title
time of tetter disappearance
Description
Refering to the length of time when the tetter due to HFMD disappears, characterised by scab(s) or dropping; and time of oral ulcer concrescence, etc.
Time Frame
10 days
Title
direct medical cost
Description
Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
Time Frame
10 days
Title
safety outcome
Description
Calculated by adverse event.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoliang Zhang
Organizational Affiliation
An'Hui Chinese Medical College Affiliated No.1 Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Guilin Medical College
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiong Li
Phone
13737728526
Email
yuanyanhui_888@163.com
First Name & Middle Initial & Last Name & Degree
Xiong Li
Facility Name
Liuzhou Worker's Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liuping Tang
Phone
18977228768
Email
yongren126zeng@126.com
First Name & Middle Initial & Last Name & Degree
Zhe Guo
Phone
13978009767
Email
sdy761212@163.com
First Name & Middle Initial & Last Name & Degree
Liuping Tang
First Name & Middle Initial & Last Name & Degree
Zhe Guo
Facility Name
Liuzhou People's Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tong Yang
Phone
13977286628
Email
zhoubing-1995@163.com
First Name & Middle Initial & Last Name & Degree
Tong Yang
Facility Name
Shenzhen Maternity & Child Healthcare Hospital
City
Shenzhen
State/Province
Guangzhou
ZIP/Postal Code
518028
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinying Zou
Phone
13129559135
Email
Xuzhiymr@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Xinying Zou
Facility Name
Jiangxi Provincial Children's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingxiong Zhu
Phone
15979003000
Email
Zhuqingxiong2000@163.com
First Name & Middle Initial & Last Name & Degree
Qingxiong Zhu

12. IPD Sharing Statement

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A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

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