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

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ClinicalTrials.gov Identifier: NCT01145664
Recruitment Status : Unknown
Verified May 2010 by Beijing YouAn Hospital.
Recruitment status was:  Recruiting
First Posted : June 17, 2010
Last Update Posted : June 17, 2010
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

Study Description
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Brief Summary:
The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.

Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease Drug: Herbal concentrate-granules plus western therapy Drug: Reduning Injection plus western therapy Drug: Western therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2010
Estimated Primary Completion Date : August 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Western therapy Drug: Western therapy
Intervention time: 7-10 days; Follow-up time: 5 days.
Experimental: Herbal concentrate-granules plus western therapy Drug: Herbal concentrate-granules plus western therapy
Intervention time: 7-10 days; Follow-up time: 5 days.
Experimental: Reduning Injection plus western therapy Drug: Reduning Injection plus western therapy
Intervention time: 7-10 days; Follow-up time: 5 days.


Outcome Measures
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Primary Outcome Measures :
  1. incidence of complications [ Time Frame: 15 days ]
  2. incidence of critically ill patients [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. case fatality rate [ Time Frame: 15 days ]
  2. time of symptom disappearance [ Time Frame: 15 days ]
  3. time of bringing down a fever [ Time Frame: 15 days ]
  4. length of stay [ Time Frame: 15 days ]
  5. dose and usage of hormones [ Time Frame: 15 days ]
  6. safety outcome(adverse effects) [ Time Frame: 15 days ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. not more than 24 hours of occurrence of severe symptoms
  3. age of 1-13 years
  4. Patients or their guardians agree to participate in this study and signed the informed consent form

Exclusion Criteria:

  1. Suffering from neurogenic pulmonary edema, heart or lung failure.
  2. Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
  3. the history of allergies on Chinese medicine
  4. the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
  5. using hormonal therapy
  6. Attending other clinical studies on hand-foot-mouth disease
  7. Patients or their guardians suffering from mental illness
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145664


Locations
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China, Guangdong
Guangzhou Women and Children Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Yi Xu    13416427315      
Sub-Investigator: Yi Xu         
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China
Contact: Dan Wei    13977166581      
Sub-Investigator: Dan Wei         
China, Henan
Kaifeng Municipal Children's Hospital Recruiting
Kaifeng, Henan, China
Contact: Xi Zhang    13069307700      
Sub-Investigator: Xi Zhang         
China, Hunan
Hunan Provincial Children's Hospital Recruiting
Changsha, Hunan, China
Contact: Shuangjie Li    15874162057      
Sub-Investigator: Shuangjie Li         
China
Anhui Provincial Children's Hospital Recruiting
Anhui, China
Contact: Biquan Chen    13856065978      
Sub-Investigator: Biquan Chen         
Beijing YouAn Hospital，Capital Medical University Recruiting
Beijing, China
Contact: Xiuhui li, MD    86-10-93997040    lixiuhui@sohu.com   
Principal Investigator: Xiuhui Li, MD         
Sponsors and Collaborators
Beijing YouAn Hospital
State Administration of Traditional Chinese Medicine of the People's Republic of China
China Academy of Chinese Medical Sciences
Beijing University of Chinese Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xiuhui Li, Beijing YouAn Hospital，Capital Medical University
ClinicalTrials.gov Identifier: NCT01145664    
Obsolete Identifiers: NCT01314794
Other Study ID Numbers: 200907001-3
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: June 17, 2010
Last Verified: May 2010
Keywords provided by Beijing YouAn Hospital:
Chinese medicines
Severe hand-foot-mouth diseases
effectiveness
safety
Additional relevant MeSH terms:
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Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Stomatognathic Diseases
Picornaviridae Infections
 RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections