Back to resultsA Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Primary Purpose
Hand, Foot and Mouth Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Western therapy
TCM Syndrome Differentiation and Treatment
Western therapy plus TCM treatment
Sponsored by
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, Traditional Chinese Medicine, Effectiveness, Safety
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.
Sites / Locations
- Anhui Provincial Children's Hospital
- The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
- Beijing Ditan Hospital
- Beijing You-An Hospital
- Chongqing Hospital of Traditional Chinese Medicine
- Fuzhou Infectious Disease Hospital
- Xiamen Hospital of Traditional Chinese Medicine
- First Hospital of Lanzhou University
- Shenzhen Third People's Hospital
- The Fifth Hospital of Shijiazhuang, Hebei
- Wuhan Hospital for Infectious Diseases
- Huhehaote Second Hospital
- Ninth Hospital of Nanchang
- Changchun Infectious Diseases Hospital
- Ningxia Hui Autonomous Region Forth People's Hospital
- The Eighth Hospital of Xi'an City
- Shanghai Public Health Center
- Chengdu Hospital for Infectious Diseases
- Xinjiang Hongxing Hospital
- First Affiliated Hospital to Kunming Medical College
- The Sixth People's Hospital of Hangzhou
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Western therapy
TCM treatment
Western therapy plus TCM treatment
Arm Description
The combination of both western therapy and TCM treatment.
Outcomes
Primary Outcome Measures
time to onset
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 and oral ulcer disappearance
Refering to the length of time when the tetter due to HFMD disappears, characterised by no new tetter and oral ulcer develops, 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
NCT ID
NCT01182532
First Posted
August 16, 2010
Last Updated
July 20, 2012
Sponsor
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Collaborators
Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01182532
Brief Title
A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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 study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).
Detailed Description
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of traditional Chinese medicine for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.
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, Traditional Chinese Medicine, Effectiveness, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Western therapy
Arm Type
Active Comparator
Arm Title
TCM treatment
Arm Type
Experimental
Arm Title
Western therapy plus TCM treatment
Arm Type
Experimental
Arm Description
The combination of both western therapy and TCM treatment.
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)
TCM Syndrome Differentiation and Treatment
Intervention Description
Lung-Spleen Damp-Heat Syndrome Symptoms: Fever, maculopapule and herpes on hand, foot and buttock; herpes on oral mucous membrane; redness in throat, salivation, tiredness, faint red tongue or reddish tongue, greasy fur, speedy pulse, red and purple fingerprint.
Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Lonicera japonica Thunb (Jin Yin Hua), Scutellaria baicalensis Georgi (Huang Qin), etc.
Dosage: Adjusting by age and weight of patients. Decoction.
Dampness-Heat Retention Syndrome Symptoms: High fever, dirty color of tetter, tiredness, oral ulcer, reddish tongue or deep red tongue, little saliva, yellow and greasy fur, fine and rapid pulse, deep purple fingerprint.
Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Gardenia jasminoides Ellis (rough Zhi Zi), Scutellaria baicalensis Georgi (Huang Qin), etc.
Dosage: Adjusting by age and weight of patients. Decoction.
Intervention Type
Other
Intervention Name(s)
Western therapy plus TCM treatment
Intervention Description
Symptomatic treatment using the same treatment methods in western therapy group;
Syndrome differentiation and treatment adopting the same methods in TCM treatment group.
Primary Outcome Measure Information:
Title
time to onset
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 and oral ulcer disappearance
Description
Refering to the length of time when the tetter due to HFMD disappears, characterised by no new tetter and oral ulcer develops, 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
Anhui Provincial Children's Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Ditan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing You-An Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing Hospital of Traditional Chinese Medicine
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Fuzhou Infectious Disease Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Xiamen Hospital of Traditional Chinese Medicine
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gausu
Country
China
Facility Name
Shenzhen Third People's Hospital
City
Shenzhen
State/Province
Guangzhou
Country
China
Facility Name
The Fifth Hospital of Shijiazhuang, Hebei
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Wuhan Hospital for Infectious Diseases
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Huhehaote Second Hospital
City
Huhehaote
State/Province
Inner Mongolia
Country
China
Facility Name
Ninth Hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Changchun Infectious Diseases Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Ningxia Hui Autonomous Region Forth People's Hospital
City
Yinchuan
State/Province
Ningxia Hui Autonomous
Country
China
Facility Name
The Eighth Hospital of Xi'an City
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Shanghai Public Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Chengdu Hospital for Infectious Diseases
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Xinjiang Hongxing Hospital
City
Urumuqi
State/Province
Xinjiang
Country
China
Facility Name
First Affiliated Hospital to Kunming Medical College
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
The Sixth People's Hospital of Hangzhou
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
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A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
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