A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
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|ClinicalTrials.gov Identifier: NCT01182025|
Recruitment Status : Unknown
Verified August 2010 by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine.
Recruitment status was: Recruiting
First Posted : August 16, 2010
Last Update Posted : August 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hand, Foot and Mouth Disease||Other: Western therapy Drug: Xiyanping Injection Drug: Xiyanping Injection with western medicine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||December 2011|
|Active Comparator: Western therapy||
Other: Western therapy
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.
|Experimental: Xiyanping Injection||
Drug: Xiyanping Injection
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.
|Experimental: Xiyanping Injection with western medicine||
Drug: Xiyanping Injection with western medicine
- time of bringing down the fever [ Time Frame: 10 days ]Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
- time of body temperature going back to normal [ Time Frame: 10 days ]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.
- time of symptom disappearance [ Time Frame: 10 days ]Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
- case severity rate [ Time Frame: 10 days ]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.
- time of tetter disappearance [ Time Frame: 10 days ]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.
- direct medical cost [ Time Frame: 10 days ]Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
- safety outcome [ Time Frame: 10 days ]Calculated by adverse event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182025
|Affiliated Hospital of Guilin Medical College||Recruiting|
|Guilin, Guangxi, China, 541001|
|Contact: Xiong Li 13737728526 firstname.lastname@example.org|
|Principal Investigator: Xiong Li|
|Liuzhou Worker's Hospital||Recruiting|
|Liuzhou, Guangxi, China, 541001|
|Contact: Liuping Tang 18977228768 email@example.com|
|Contact: Zhe Guo 13978009767 firstname.lastname@example.org|
|Principal Investigator: Liuping Tang|
|Principal Investigator: Zhe Guo|
|Liuzhou People's Hospital||Recruiting|
|Liuzhou, Guangxi, China, 545001|
|Contact: Tong Yang 13977286628 email@example.com|
|Principal Investigator: Tong Yang|
|Shenzhen Maternity & Child Healthcare Hospital||Recruiting|
|Shenzhen, Guangzhou, China, 518028|
|Contact: Xinying Zou 13129559135 Xuzhiymr@yahoo.com.cn|
|Principal Investigator: Xinying Zou|
|Jiangxi Provincial Children's Hospital||Recruiting|
|Nanchang, Jiangxi, China, 330006|
|Contact: Qingxiong Zhu 15979003000 Zhuqingxiong2000@163.com|
|Principal Investigator: Qingxiong Zhu|
|Principal Investigator:||Guoliang Zhang||An'Hui Chinese Medical College Affiliated No.1 Hospital|