Clinical trial NCT01554930: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hand, Foot, and Mouth Disease
Keywords: HFMD
Traditional Chinese Medicine
Xiyanping
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: China Academy of Chinese Medical Sciences
name: Beijing YouAn Hospital
name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: Beijing University of Chinese Medicine
First posted: 2012-03-15
Enrollment: 230
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: complication rate
timeFrame: 15 days
Secondary outcomes:
measure: time of body temperature going back to normal
timeFrame: 15 days
measure: time of symptom disappearance
timeFrame: 15 days
measure: safety outcome
timeFrame: 15 days
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Handan
country: China
facility: Handan Maternal and Child Health Care Hospital
state: Hebei
city: Nanchang
country: China
facility: Jiangxi Children's Hospital
state: Jiangxi
Study officials:
affiliation: Beijing You-An Hospital
name: Li Xiu hui, PhD
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: Zhang Guo liang, PhD
role: STUDY_CHAIR
affiliation: Handan Maternal and Child Health Care Hospital
name: Shi Qin sheng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangxi Children's Hospital
name: Zhu Qin xiong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: LiuZhou People's Hospital
name: Yang tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.