Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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): 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|