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A Clinical Trial To Evaluate Reduning 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
Reduning Injection
Reduning Injection plus western therapy
Sponsored by
Jiangsu Kanion Pharmaceutical Co., Ltd
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, Reduning Injection, Effectiveness, Safety

Eligibility Criteria

1 Year - 13 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 mild symptoms, with an armpit temperature of more than 37.5 degrees Celsius.
  • Less than 48 hours of occurrence of tetter or herpes.
  • Age of 1-13 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 the experimental medicine, or severe allergies to other medicines.
  • Using other western medicine or Chinese medicine for treating HFMD when consulted.
  • Attending other clinical studies on HFMD after diagnosed.

Sites / Locations

  • An'Hui Provincial Children's HospitalRecruiting
  • Fujian Provincial Quanzhou City Children's HospitalRecruiting
  • The Fifth Hospital of Shijiazhuang CityRecruiting
  • Kaifeng Municipal Children's HospitalRecruiting
  • Hunan Provincial Children's HospitalRecruiting
  • Shanghai Public Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Western therapy

Reduning Injection

Reduning Injection plus western therapy

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.
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.
dose and usage of medicine
Refering to the dose and frequency of using the medicine.
case severity rate
Refering to the ratio of patient with mild type of HFMD to severe type.
adverse reaction incidence
Calculated by adverse event.

Full Information

First Posted
August 4, 2010
Last Updated
August 4, 2010
Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01175915
Brief Title
A Clinical Trial To Evaluate Reduning 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
May 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing University of Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for mild type of hand-foot-mouth disease.
Detailed Description
By adopting a multi-center, prospective, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Reduning Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and to provide medical evidence of Reduning Injection for HFMD, especially to offer suggestions in clinical practice.

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, Reduning Injection, Effectiveness, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Western therapy
Arm Type
Active Comparator
Arm Title
Reduning Injection
Arm Type
Experimental
Arm Title
Reduning Injection plus western therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Western therapy
Intervention Description
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 lasting for more than 2 hours; No specific treatment for tetter and ulcer, but Bingpeng powder, Watermelon tablet or frost for oral herpes. Intervention time: 3-7 days; Follow-up time: 3 days.
Intervention Type
Other
Intervention Name(s)
Reduning Injection
Intervention Description
Lifestyle counseling, vitamin supplementation if necessary, and non-use of antibiotics; Reduning Injection, 0.5~15ml, depending on patient's condition, IV per day, or according to the instruction; Using Ibuprofen suspension when patient's temperature higher than 39 degree Celsius lasting for more than 2 hours. Intervention time: 3-7 days; Follow-up time: 3 days.
Intervention Type
Other
Intervention Name(s)
Reduning Injection plus western therapy
Intervention Description
General treatment including lifestyle counseling, vitamin supplementation if necessary, non-use of antibiotics, and symptomatic treatment as follows; Symptomatic treatment by western therapy adopting the same plan in western therapy comparator group; Symptomatic treatment by Reduning Injection adopting the same plan in Reduning Injection experimental group. Intervention time: 3-7 days; Follow-up time: 3 days.
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
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
dose and usage of medicine
Description
Refering to the dose and frequency of using the medicine.
Time Frame
10 days
Title
case severity rate
Description
Refering to the ratio of patient with mild type of HFMD to severe type.
Time Frame
10 days
Title
adverse reaction incidence
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
13 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 mild symptoms, with an armpit temperature of more than 37.5 degrees Celsius. Less than 48 hours of occurrence of tetter or herpes. Age of 1-13 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 the experimental medicine, or severe allergies to other medicines. Using other western medicine or Chinese medicine for treating HFMD when consulted. Attending other clinical studies on HFMD after diagnosed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Xiao
Organizational Affiliation
Jiangsu Kanion Pharmaceutical Co., Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
An'Hui Provincial Children's Hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biquan Chen
Phone
13856065978
Email
anhuicbq4049@sina.com
First Name & Middle Initial & Last Name & Degree
Biquan Chen
Facility Name
Fujian Provincial Quanzhou City Children's Hospital
City
Quanzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqiang Zhuo
Phone
13905984912
Email
zzq2191190@tom.com
First Name & Middle Initial & Last Name & Degree
Zhiqiang Zhuo
Facility Name
The Fifth Hospital of Shijiazhuang City
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haojie Zheng
Phone
13933872363
Email
zhj76711@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Haojie Zheng
Facility Name
Kaifeng Municipal Children's Hospital
City
Kaifeng
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Zhang
Phone
13069307700
Email
kfzhangxi@sohu.com
First Name & Middle Initial & Last Name & Degree
Xi Zhang
Facility Name
Hunan Provincial Children's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuangjie Li
Phone
15874162057
Email
lesjie62@sohu.com
First Name & Middle Initial & Last Name & Degree
Shuangjie Li
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Mu
Phone
13818869248
Email
ypmu8888@126.com
First Name & Middle Initial & Last Name & Degree
Yongping Mu

12. IPD Sharing Statement

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A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

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