drugset / Trial / NCT01554930
Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease
Completed
230 enrolled
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Beijing University of Chinese Medicine · collabBeijing YouAn Hospital · collabChina Academy of Chinese Medical Sciences · collabThe First Affiliated Hospital of Anhui University of Traditional Chinese Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2010-05
- Primary completion
- 2010-11
- Completion
- 2011-12
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Xiyanping | Unknown | 5 mg/kg | Intravenous |
| Subject | Xiyanping | Unknown | 10 mg/kg | Intravenous |
| Comparator | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 1 g/kg | — |
| Comparator | Mannitol | Diagnostic / imaging agent | 0.5 g/kg | Intravenous |
| Comparator | Mannitol | Diagnostic / imaging agent | 1 g/kg | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | 1 mg/kg | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | 2 mg/kg | Intravenous |