Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease
NCT ID: NCT01554930
Last Updated: 2012-03-15
Study Results
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Basic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2010-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Western therapy
Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)
Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
Xiyanping injection plus western therapy
Xiyanping injection plus western therapy
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.
Interventions
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Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)
Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
Xiyanping injection plus western therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
1 Year
13 Years
ALL
No
Sponsors
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China Academy of Chinese Medical Sciences
OTHER
Beijing YouAn Hospital
OTHER
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
Beijing University of Chinese Medicine
OTHER
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Li Xiu hui, PhD
Role: STUDY_CHAIR
Beijing You-An Hospital
Zhang Guo liang, PhD
Role: STUDY_CHAIR
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Shi Qin sheng, PhD
Role: PRINCIPAL_INVESTIGATOR
Handan Maternal and Child Health Care Hospital
Zhu Qin xiong, PhD
Role: PRINCIPAL_INVESTIGATOR
Jiangxi Children's Hospital
Yang tong, PhD
Role: PRINCIPAL_INVESTIGATOR
LiuZhou People's Hospital
Locations
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Liuzhou People's Hospital
Liuzhou, Guangxi, China
Handan Maternal and Child Health Care Hospital
Handan, Hebei, China
Jiangxi Children's Hospital
Nanchang, Jiangxi, China
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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200907001-3
Identifier Type: -
Identifier Source: org_study_id
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