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| Name | Class |
|---|---|
| Beijing University of Chinese Medicine | OTHER |
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The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for mild type of hand-foot-mouth disease.
By adopting a multi-center, prospective, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Reduning Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and to provide medical evidence of Reduning Injection for HFMD, especially to offer suggestions in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Western therapy | Active Comparator |
| |
| Reduning Injection | Experimental |
| |
| Reduning Injection plus western therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Western therapy | Other |
Intervention time: 3-7 days; Follow-up time: 3 days. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Xiao | Jiangsu Kanion Pharmaceutical Co., Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| An'Hui Provincial Children's Hospital | Recruiting | Hefei | An'Hui | China |
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|
| Reduning Injection | Other |
Intervention time: 3-7 days; Follow-up time: 3 days. |
|
| Reduning Injection plus western therapy | Other |
Intervention time: 3-7 days; Follow-up time: 3 days. |
|
| 10 days |
| dose and usage of medicine | Refering to the dose and frequency of using the medicine. | 10 days |
| case severity rate | Refering to the ratio of patient with mild type of HFMD to severe type. | 10 days |
| adverse reaction incidence | Calculated by adverse event. | 10 days |
| Fujian Provincial Quanzhou City Children's Hospital | Recruiting | Quanzhou | Fujian | China |
|
| The Fifth Hospital of Shijiazhuang City | Recruiting | Shijiazhuang | Hebei | China |
|
| Kaifeng Municipal Children's Hospital | Recruiting | Kaifeng | Henan | China |
|
| Hunan Provincial Children's Hospital | Recruiting | Changsha | Hunan | China |
|
| Shanghai Public Health Clinical Center | Recruiting | Shanghai | Shanghai Municipality | 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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| ID | Term |
|---|---|
| C000596355 | reduning |
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