Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease
A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease
1 other identifier
interventional
230
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 11, 2012
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedMarch 15, 2012
March 1, 2012
6 months
March 11, 2012
March 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
15 days
Secondary Outcomes (3)
time of body temperature going back to normal
15 days
time of symptom disappearance
15 days
safety outcome
15 days
Study Arms (2)
Western therapy
ACTIVE COMPARATORXiyanping injection plus western therapy
EXPERIMENTALInterventions
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: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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Liuzhou People's Hospital
Liuchow, Guangxi, China
Handan Maternal and Child Health Care Hospital
Handan, Hebei, China
Jiangxi Children's Hospital
Nanchang, Jiangxi, China
Related Publications (5)
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.
PMID: 18439374BACKGROUNDHosoya 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.
PMID: 17093028BACKGROUNDYoke-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.
PMID: 16939656BACKGROUNDChang 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.
PMID: 12042582BACKGROUNDShen 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.
PMID: 10588115BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Li Xiu hui, PhD
Beijing You-An Hospital
- STUDY CHAIR
Zhang Guo liang, PhD
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- PRINCIPAL INVESTIGATOR
Shi Qin sheng, PhD
Handan Maternal and Child Health Care Hospital
- PRINCIPAL INVESTIGATOR
Zhu Qin xiong, PhD
Jiangxi Children's Hospital
- PRINCIPAL INVESTIGATOR
Yang tong, PhD
LiuZhou People's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2012
First Posted
March 15, 2012
Study Start
May 1, 2010
Primary Completion
November 1, 2010
Study Completion
December 1, 2011
Last Updated
March 15, 2012
Record last verified: 2012-03