A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Recruitment status was Recruiting
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The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.
Condition | Intervention |
---|---|
Hand, Foot and Mouth Disease |
Other: Western therapy Drug: Xiyanping Injection Drug: Xiyanping Injection with western medicine |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- time of bringing down the fever [ Time Frame: 10 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Calculated by adverse event.
Estimated Enrollment: | 360 |
Study Start Date: | June 2010 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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
|
Detailed Description:
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.
Ages Eligible for Study: | 1 Year to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination.
- Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes.
- Age of 1-14 years.
- Patients or their guardians agree to participate in this study and signed the informed consent form.
Exclusion Criteria:
- Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
- With history of allergies on traditional Chinese medicine.
- Patients or their guardians suffering from Psychiatric diseases.
- Attending other clinical studies on HFMD after diagnosed.
China, Guangxi | |
Affiliated Hospital of Guilin Medical College | Recruiting |
Guilin, Guangxi, China, 541001 | |
Contact: Xiong Li 13737728526 yuanyanhui_888@163.com | |
Principal Investigator: Xiong Li | |
Liuzhou Worker's Hospital | Recruiting |
Liuzhou, Guangxi, China, 541001 | |
Contact: Liuping Tang 18977228768 yongren126zeng@126.com | |
Contact: Zhe Guo 13978009767 sdy761212@163.com | |
Principal Investigator: Liuping Tang | |
Principal Investigator: Zhe Guo | |
Liuzhou People's Hospital | Recruiting |
Liuzhou, Guangxi, China, 545001 | |
Contact: Tong Yang 13977286628 zhoubing-1995@163.com | |
Principal Investigator: Tong Yang | |
China, Guangzhou | |
Shenzhen Maternity & Child Healthcare Hospital | Recruiting |
Shenzhen, Guangzhou, China, 518028 | |
Contact: Xinying Zou 13129559135 Xuzhiymr@yahoo.com.cn | |
Principal Investigator: Xinying Zou | |
China, Jiangxi | |
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 |
No publications provided
Responsible Party: | Guoliang Zhang, The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine |
ClinicalTrials.gov Identifier: | NCT01182025 History of Changes |
Other Study ID Numbers: | 200907001-4 |
Study First Received: | August 13, 2010 |
Last Updated: | August 16, 2010 |
Health Authority: | China: Ethics Committee |
Keywords provided by The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine:
Mild type of hand, foot and mouth disease Xiyanping Injection Effectiveness Safety |
Additional relevant MeSH terms:
Foot-and-Mouth Disease Hand, Foot and Mouth Disease Mouth Diseases Picornaviridae Infections RNA Virus Infections |
Virus Diseases Coxsackievirus Infections Enterovirus Infections Stomatognathic Diseases |
ClinicalTrials.gov processed this record on October 17, 2012