- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01182025
A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
August 16, 2010 updated by: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
360
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangxi
-
Guilin, Guangxi, China, 541001
- Recruiting
- Affiliated Hospital of Guilin Medical College
-
Contact:
- Xiong Li
- Phone Number: 13737728526
- Email: yuanyanhui_888@163.com
-
Principal Investigator:
- Xiong Li
-
Liuzhou, Guangxi, China, 541001
- Recruiting
- Liuzhou worker's hospital
-
Contact:
- Liuping Tang
- Phone Number: 18977228768
- Email: yongren126zeng@126.com
-
Contact:
- Zhe Guo
- Phone Number: 13978009767
- Email: sdy761212@163.com
-
Principal Investigator:
- Liuping Tang
-
Principal Investigator:
- Zhe Guo
-
Liuzhou, Guangxi, China, 545001
- Recruiting
- Liuzhou People's Hospital
-
Contact:
- Tong Yang
- Phone Number: 13977286628
- Email: zhoubing-1995@163.com
-
Principal Investigator:
- Tong Yang
-
-
Guangzhou
-
Shenzhen, Guangzhou, China, 518028
- Recruiting
- Shenzhen Maternity & Child Healthcare Hospital
-
Contact:
- Xinying Zou
- Phone Number: 13129559135
- Email: Xuzhiymr@yahoo.com.cn
-
Principal Investigator:
- Xinying Zou
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330006
- Recruiting
- Jiangxi Provincial Children's Hospital
-
Contact:
- Qingxiong Zhu
- Phone Number: 15979003000
- Email: Zhuqingxiong2000@163.com
-
Principal Investigator:
- Qingxiong Zhu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Western therapy
|
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.
|
Experimental: 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
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 days
|
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.
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 days
|
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.
|
10 days
|
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.
|
10 days
|
safety outcome
Time Frame: 10 days
|
Calculated by adverse event.
|
10 days
|
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.
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Guoliang Zhang, An'Hui Chinese Medical College Affiliated No.1 Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Anticipated)
May 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
August 13, 2010
First Submitted That Met QC Criteria
August 13, 2010
First Posted (Estimate)
August 16, 2010
Study Record Updates
Last Update Posted (Estimate)
August 17, 2010
Last Update Submitted That Met QC Criteria
August 16, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200907001-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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