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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
  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:


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.

  1. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;
  2. 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
  1. Symptomatic treatment using the same treatment methods in western therapy group;
  2. 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
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 People's Hospital Recruiting
Liuzhou, Guangxi, China, 545001
Contact: Tong Yang    13977286628    zhoubing-1995@163.com   
Principal Investigator: Tong Yang         
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         
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

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 University 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
Coxsackievirus Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Stomatognathic Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014