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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hand, Foot and Mouth Disease	Other: Western therapy; Drug: Xiyanping Injection; Drug: Xiyanping Injection with western medicine	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	360 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	June 2010
Estimated Primary Completion Date :	May 2011
Estimated Study Completion Date :	December 2011

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Western therapy	Other: Western therapy; Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.; Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;; Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;
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; Symptomatic treatment using the same treatment methods in western therapy group;; Symptomatic treatment using the same treatment methods in Xiyanpin injection group.

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. safety outcome [ Time Frame: 10 days ]
   Calculated by adverse event.

Eligibility Criteria

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Ages Eligible for Study:	1 Year to 14 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Beijing University of Chinese Medicine

China Academy of Chinese Medical Sciences

Investigators

Principal Investigator:	Guoliang Zhang	An'Hui Chinese Medical College Affiliated No.1 Hospital

More Information

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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
First Posted:	August 16, 2010
Last Update Posted:	August 17, 2010
Last Verified:	August 2010

Keywords provided by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine:

Mild type of hand, foot and mouth disease; Xiyanping Injection; Effectiveness; Safety

Additional relevant MeSH terms:

Mouth Diseases; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Stomatognathic Diseases; Picornaviridae Infections	RNA Virus Infections; Virus Diseases; Coxsackievirus Infections; Enterovirus Infections