A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
June 16, 2010 updated by: Beijing YouAn Hospital
The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
390
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
-
-
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Anhui, China
- Recruiting
- Anhui Provincial Children's Hospital
-
Contact:
- Biquan Chen
- Phone Number: 13856065978
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Sub-Investigator:
- Biquan Chen
-
Beijing, China
- Recruiting
- Beijing Youan Hospital,Capital Medical University
-
Principal Investigator:
- Xiuhui Li, MD
-
Contact:
- Xiuhui li, MD
- Phone Number: 86-10-93997040
- Email: lixiuhui@sohu.com
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- Guangzhou Women and Children Hospital
-
Contact:
- Yi Xu
- Phone Number: 13416427315
-
Sub-Investigator:
- Yi Xu
-
-
Guangxi
-
Nanning, Guangxi, China
- Recruiting
- The First affiliated hospital of GuangXi medical university
-
Contact:
- Dan Wei
- Phone Number: 13977166581
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Sub-Investigator:
- Dan Wei
-
-
Henan
-
Kaifeng, Henan, China
- Recruiting
- Kaifeng Municipal Children's Hospital
-
Contact:
- Xi Zhang
- Phone Number: 13069307700
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Sub-Investigator:
- Xi Zhang
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-
Hunan
-
Changsha, Hunan, China
- Recruiting
- Hunan Provincial Children's Hospital
-
Contact:
- Shuangjie Li
- Phone Number: 15874162057
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Sub-Investigator:
- Shuangjie Li
-
-
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 13 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
- not more than 24 hours of occurrence of severe symptoms
- age of 1-13 years
- Patients or their guardians agree to participate in this study and signed the informed consent form
Exclusion Criteria:
- Suffering from neurogenic pulmonary edema, heart or lung failure.
- Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
- the history of allergies on Chinese medicine
- the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
- using hormonal therapy
- Attending other clinical studies on hand-foot-mouth disease
- Patients or their guardians suffering from mental illness
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
|
Intervention time: 7-10 days; Follow-up time: 5 days.
|
|
Experimental: Herbal concentrate-granules plus western therapy
|
Intervention time: 7-10 days; Follow-up time: 5 days.
|
|
Experimental: Reduning Injection plus western therapy
|
Intervention time: 7-10 days; Follow-up time: 5 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
incidence of complications
Time Frame: 15 days
|
15 days
|
|
incidence of critically ill patients
Time Frame: 15 days
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
case fatality rate
Time Frame: 15 days
|
15 days
|
|
time of symptom disappearance
Time Frame: 15 days
|
15 days
|
|
time of bringing down a fever
Time Frame: 15 days
|
15 days
|
|
length of stay
Time Frame: 15 days
|
15 days
|
|
dose and usage of hormones
Time Frame: 15 days
|
15 days
|
|
safety outcome(adverse effects)
Time Frame: 15 days
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
May 1, 2010
Primary Completion (Anticipated)
August 1, 2010
Study Registration Dates
First Submitted
June 16, 2010
First Submitted That Met QC Criteria
June 16, 2010
First Posted (Estimate)
June 17, 2010
Study Record Updates
Last Update Posted (Estimate)
June 17, 2010
Last Update Submitted That Met QC Criteria
June 16, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200907001-3
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.