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Effectiveness and Safety of Chinese Medicine to Treat 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 (mannitol, methylprednisolone, immunoglobulin, febrifuge)
Xiyanping injection plus western therapy
Sponsored by
Jiangxi Qingfeng 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 HFMD, Traditional Chinese Medicine, Xiyanping

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 24 hours of occurrence of fever and/or 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 diseases such as neurogenic pulmonary edema, cardiopulmonary failure.
  • 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 who using glucocorticoids for based diseases.
  • Patients who having history of hemolysis.
  • Patients or their guardians suffering from Psychiatric diseases.
  • Attending other clinical studies on HFMD after diagnosed.

Sites / Locations

  • Liuzhou People's Hospital
  • Handan Maternal and Child Health Care Hospital
  • Jiangxi Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Western therapy

Xiyanping injection plus western therapy

Arm Description

Outcomes

Primary Outcome Measures

complication rate
Refering to the ratio of patient having complications such as pulmonary edema, myocarditis，damage of central nervous system，shock, respiratory failure, multiple organ failur etc.

Secondary Outcome Measures

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.
time of symptom disappearance
Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.
safety outcome
Calculated by adverse event

Full Information

First Posted
March 11, 2012
Last Updated
March 14, 2012
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Collaborators
China Academy of Chinese Medical Sciences, Beijing YouAn Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01554930
Brief Title
Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease
Official Title
A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Collaborators
China Academy of Chinese Medical Sciences, Beijing YouAn Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Beijing University of Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type 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 a traditional Chinese medicine, Xiyanping injection,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
HFMD, Traditional Chinese Medicine, Xiyanping

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Western therapy
Arm Type
Active Comparator
Arm Title
Xiyanping injection plus western therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)
Intervention Description
Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
Intervention Type
Drug
Intervention Name(s)
Xiyanping injection plus western therapy
Intervention Description
Xiyanping injection:5-10mg/kg/d (0.2-0.4ml/kg/d),qd ivgtt; Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
Primary Outcome Measure Information:
Title
complication rate
Description
Refering to the ratio of patient having complications such as pulmonary edema, myocarditis，damage of central nervous system，shock, respiratory failure, multiple organ failur etc.
Time Frame
15 days
Secondary Outcome Measure Information:
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
15 days
Title
time of symptom disappearance
Description
Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.
Time Frame
15 days
Title
safety outcome
Description
Calculated by adverse event
Time Frame
15 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 24 hours of occurrence of fever and/or 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 diseases such as neurogenic pulmonary edema, cardiopulmonary failure. 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 who using glucocorticoids for based diseases. Patients who having history of hemolysis. 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
Li Xiu hui, PhD
Organizational Affiliation
Beijing You-An Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhang Guo liang, PhD
Organizational Affiliation
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shi Qin sheng, PhD
Organizational Affiliation
Handan Maternal and Child Health Care Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhu Qin xiong, PhD
Organizational Affiliation
Jiangxi Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yang tong, PhD
Organizational Affiliation
LiuZhou People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liuzhou People's Hospital
City
Liuzhou
State/Province
Guangxi
Country
China
Facility Name
Handan Maternal and Child Health Care Hospital
City
Handan
State/Province
Hebei
Country
China
Facility Name
Jiangxi Children's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
18439374
Citation
Hamaguchi T, Fujisawa H, Sakai K, Okino S, Kurosaki N, Nishimura Y, Shimizu H, Yamada M. Acute encephalitis caused by intrafamilial transmission of enterovirus 71 in adult. Emerg Infect Dis. 2008 May;14(5):828-30. doi: 10.3201/eid1405.071121.
Results Reference
background
PubMed Identifier
17093028
Citation
Hosoya M, Kawasaki Y, Sato M, Honzumi K, Hayashi A, Hiroshima T, Ishiko H, Kato K, Suzuki H. Genetic diversity of coxsackievirus A16 associated with hand, foot, and mouth disease epidemics in Japan from 1983 to 2003. J Clin Microbiol. 2007 Jan;45(1):112-20. doi: 10.1128/JCM.00718-06. Epub 2006 Nov 8.
Results Reference
background
PubMed Identifier
16939656
Citation
Yoke-Fun C, AbuBakar S. Phylogenetic evidence for inter-typic recombination in the emergence of human enterovirus 71 subgenotypes. BMC Microbiol. 2006 Aug 30;6:74. doi: 10.1186/1471-2180-6-74.
Results Reference
background
PubMed Identifier
12042582
Citation
Chang LY, King CC, Hsu KH, Ning HC, Tsao KC, Li CC, Huang YC, Shih SR, Chiou ST, Chen PY, Chang HJ, Lin TY. Risk factors of enterovirus 71 infection and associated hand, foot, and mouth disease/herpangina in children during an epidemic in Taiwan. Pediatrics. 2002 Jun;109(6):e88. doi: 10.1542/peds.109.6.e88.
Results Reference
background
PubMed Identifier
10588115
Citation
Shen WC, Chiu HH, Chow KC, Tsai CH. MR imaging findings of enteroviral encephaloymelitis: an outbreak in Taiwan. AJNR Am J Neuroradiol. 1999 Nov-Dec;20(10):1889-95.
Results Reference
background

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Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease

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