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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2010 by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Beijing University of Chinese Medicine

China Academy of Chinese Medical Sciences

Information provided by:

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

ClinicalTrials.gov Identifier:

NCT01182025

First received: August 13, 2010

Last updated: August 16, 2010

Last verified: August 2010

History of Changes

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Mouth Disorders

U.S. FDA Resources

Further study details as provided by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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. 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.

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.

Eligibility


Ages Eligible for Study:	1 Year to 14 Years (Child)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182025

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


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 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

ClinicalTrials.gov processed this record on September 28, 2016

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