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| Name | Class |
|---|---|
| China Academy of Chinese Medical Sciences | OTHER |
| Beijing YouAn Hospital | OTHER |
| The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Western therapy | Active Comparator |
| |
| Xiyanping injection plus western therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge) | Drug | Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 days |
| time of symptom disappearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| Shi Qin sheng, PhD | Handan Maternal and Child Health Care Hospital | Principal Investigator |
| Zhu Qin xiong, PhD | Jiangxi Province Children's Hospital | Principal Investigator |
| Yang tong, PhD | LiuZhou People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liuzhou People's Hospital | Liuzhou | Guangxi | China | |||
| Handan Maternal and Child Health Care Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18439374 | 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. | |
| 17093028 | 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. |
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| Beijing University of Chinese Medicine |
| OTHER |
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| Xiyanping injection plus western therapy | Drug | 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. |
|
Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.
| 15 days |
| safety outcome | Calculated by adverse event | 15 days |
| Handan |
| Hebei |
| China |
| Jiangxi Children's Hospital | Nanchang | Jiangxi | China |
| 16939656 | 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. |
| 12042582 | 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. |
| 10588115 | 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. |
| ID | Term |
|---|---|
| D006232 | Hand, Foot and Mouth Disease |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| D008775 | Methylprednisolone |
| D007136 | Immunoglobulins |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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