Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease
|ClinicalTrials.gov Identifier: NCT01554930|
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : March 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hand, Foot, and Mouth Disease||Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge) Drug: Xiyanping injection plus western therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||December 2011|
|Active Comparator: Western therapy||
Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)
Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
|Experimental: Xiyanping injection plus western therapy||
Drug: Xiyanping injection plus western therapy
Xiyanping injection:5-10mg/kg/d (0.2-0.4ml/kg/d),qd ivgtt; Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
- complication rate [ Time Frame: 15 days ]Refering to the ratio of patient having complications such as pulmonary edema, myocarditis，damage of central nervous system，shock, respiratory failure, multiple organ failur etc.
- time of body temperature going back to normal [ Time Frame: 15 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: 15 days ]Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.
- safety outcome [ Time Frame: 15 days ]Calculated by adverse event
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554930
|Liuzhou People's Hospital|
|Liuzhou, Guangxi, China|
|Handan Maternal and Child Health Care Hospital|
|Handan, Hebei, China|
|Jiangxi Children's Hospital|
|Nanchang, Jiangxi, China|
|Study Chair:||Li Xiu hui, PhD||Beijing You-An Hospital|
|Study Chair:||Zhang Guo liang, PhD||The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine|
|Principal Investigator:||Shi Qin sheng, PhD||Handan Maternal and Child Health Care Hospital|
|Principal Investigator:||Zhu Qin xiong, PhD||Jiangxi Children's Hospital|
|Principal Investigator:||Yang tong, PhD||Liuzhou People's Hospital|