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| Name | Class |
|---|---|
| Beijing University of Chinese Medicine | OTHER |
| China Academy of Chinese Medical Sciences | OTHER |
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The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment 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 traditional Chinese medicine 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 |
| |
| TCM treatment | Experimental |
| |
| Western therapy plus TCM treatment | Experimental | The combination of both western therapy and TCM treatment. |
|
| 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 to onset | 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 |
|---|---|---|---|---|---|---|
| Anhui Provincial Children's Hospital | Hefei | Anhui | China | |||
| The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine |
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|
| TCM Syndrome Differentiation and Treatment | Drug |
Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Gardenia jasminoides Ellis (rough Zhi Zi), Scutellaria baicalensis Georgi (Huang Qin), etc. Dosage: Adjusting by age and weight of patients. Decoction. |
|
| Western therapy plus TCM treatment | Other |
|
|
| 10 days |
| time of tetter and oral ulcer disappearance | Refering to the length of time when the tetter due to HFMD disappears, characterised by no new tetter and oral ulcer develops, 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 |
| Hefei |
| Anhui |
| China |
| Beijing Ditan Hospital | Beijing | Beijing Municipality | China |
| Beijing You-An Hospital | Beijing | Beijing Municipality | China |
| Chongqing Hospital of Traditional Chinese Medicine | Chongqing | Chongqing Municipality | China |
| Fuzhou Infectious Disease Hospital | Fuzhou | Fujian | China |
| Xiamen Hospital of Traditional Chinese Medicine | Xiamen | Fujian | China |
| First Hospital of Lanzhou University | Lanzhou | Gausu | China |
| Shenzhen Third People's Hospital | Shenzhen | Guangzhou | China |
| The Fifth Hospital of Shijiazhuang, Hebei | Shijiazhuang | Hebei | China |
| Wuhan Hospital for Infectious Diseases | Wuhan | Hubei | China |
| Huhehaote Second Hospital | Hohhot | Inner Mongolia | China |
| Ninth Hospital of Nanchang | Nanchang | Jiangxi | China |
| Changchun Infectious Diseases Hospital | Changchun | Jilin | China |
| Ningxia Hui Autonomous Region Forth People's Hospital | Yinchuan | Ningxia Hui Autonomous | China |
| The Eighth Hospital of Xi'an City | Xi'an | Shaanxi | China |
| Shanghai Public Health Center | Shanghai | Shanghai Municipality | China |
| Chengdu Hospital for Infectious Diseases | Chengdu | Sichuan | China |
| Xinjiang Hongxing Hospital | Urumuqi | Xinjiang | China |
| First Affiliated Hospital to Kunming Medical College | Kunming | Yunnan | China |
| The Sixth People's Hospital of Hangzhou | Hangzhou | Zhejiang | 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 |
|---|---|
| D013812 | Therapeutics |
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