A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease

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

Verified May 2010 by Beijing YouAn Hospital.
Recruitment status was Recruiting

Sponsor:

Collaborators:

State Administration of Traditional Chinese Medicine of the People's Republic of China

China Academy of Chinese Medical Sciences

Beijing University of Chinese Medicine

Information provided by:

Beijing YouAn Hospital

ClinicalTrials.gov Identifier:

NCT01145664

First received: June 16, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	June 16, 2010
Last Updated Date	June 16, 2010
Start Date ^ICMJE	May 2010
Estimated Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 16, 2010)	incidence of complications [ Time Frame: 15 days ] [ Designated as safety issue: No ] incidence of critically ill patients [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: June 16, 2010)	case fatality rate [ Time Frame: 15 days ] [ Designated as safety issue: No ] time of symptom disappearance [ Time Frame: 15 days ] [ Designated as safety issue: No ] time of bringing down a fever [ Time Frame: 15 days ] [ Designated as safety issue: No ] length of stay [ Time Frame: 15 days ] [ Designated as safety issue: No ] dose and usage of hormones [ Time Frame: 15 days ] [ Designated as safety issue: No ] safety outcome(adverse effects) [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
Official Title ^ICMJE	Not Provided
Brief Summary	The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hand, Foot and Mouth Disease
Intervention ^ICMJE	Drug: Herbal concentrate-granules plus western therapy Intervention time: 7-10 days; Follow-up time: 5 days. Drug: Reduning Injection plus western therapy Intervention time: 7-10 days; Follow-up time: 5 days. Drug: Western therapy Intervention time: 7-10 days; Follow-up time: 5 days.
Study Arm (s)	Active Comparator: Western therapy Intervention: Drug: Western therapy Experimental: Herbal concentrate-granules plus western therapy Intervention: Drug: Herbal concentrate-granules plus western therapy Experimental: Reduning Injection plus western therapy Intervention: Drug: Reduning Injection plus western therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	390
Completion Date	Not Provided
Estimated Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	1 Year to 13 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01145664
Other Study ID Numbers ^ICMJE	200907001-3
Has Data Monitoring Committee	Yes
Responsible Party	Xiuhui Li, Beijing YouAn Hospital，Capital Medical University
Study Sponsor ^ICMJE	Beijing YouAn Hospital
Collaborators ^ICMJE	State Administration of Traditional Chinese Medicine of the People's Republic of China China Academy of Chinese Medical Sciences Beijing University of Chinese Medicine
Investigators ^ICMJE	Not Provided
Information Provided By	Beijing YouAn Hospital
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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