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| Name | Class |
|---|---|
| Beijing University of Chinese Medicine | OTHER |
| China Academy of Chinese Medical Sciences | OTHER |
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The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Western therapy | Active Comparator |
| |
| Xiyanping Injection | Experimental |
| |
| Xiyanping Injection with western medicine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Western therapy | Other | Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.
|
| Measure | Description | Time Frame |
|---|---|---|
| time of bringing down the fever | Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken. | 10 days |
| 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. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| time of symptom disappearance | Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used. | 10 days |
| case severity rate | Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guoliang Zhang | An'Hui Chinese Medical College Affiliated No.1 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Guilin Medical College | Recruiting | Guilin | Guangxi | 541001 | China |
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|
| Xiyanping Injection | Drug | Dosage for child medication: 5-10mg/kg/d (0.2-0.4ml/kg/d) in 5% Glucose solution, IV, with speed of 20-30 drops per minute, each day; or as directed by doctor. |
|
| Xiyanping Injection with western medicine | Drug |
|
|
| 10 days |
| time of tetter disappearance | Refering to the length of time when the tetter due to HFMD disappears, characterised by scab(s) or dropping; and time of oral ulcer concrescence, etc. | 10 days |
| direct medical cost | Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc. | 10 days |
| safety outcome | Calculated by adverse event. | 10 days |
| Liuzhou Worker's Hospital | Recruiting | Liuzhou | Guangxi | 541001 | China |
|
| Liuzhou People's Hospital | Recruiting | Liuzhou | Guangxi | 545001 | China |
|
| Shenzhen Maternity & Child Healthcare Hospital | Recruiting | Shenzhen | Guangzhou | 518028 | China |
|
| Jiangxi Provincial Children's Hospital | Recruiting | Nanchang | Jiangxi | 330006 | China |
|
| ID | Term |
|---|---|
| D006232 | Hand, Foot and Mouth Disease |
| D009059 | Mouth Diseases |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D009057 | Stomatognathic Diseases |
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