A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
|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.
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|