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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
  Purpose

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


Condition Intervention
Hand, Foot and Mouth Disease
 Drug: Herbal concentrate-granules plus western therapy
Drug: Reduning Injection plus western therapy
Drug: Western therapy

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:

U.S. FDA Resources

Further study details as provided by Beijing YouAn Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 390
Study Start Date: May 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Year to 13 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145664

Locations
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

No publications provided

Responsible Party: Xiuhui Li, Beijing YouAn Hospital，Capital Medical University
ClinicalTrials.gov Identifier: NCT01145664     History of Changes
Obsolete Identifiers: NCT01314794
Other Study ID Numbers: 200907001-3
Study First Received: June 16, 2010
Last Updated: June 16, 2010
Health Authority: China: Beijing YouAn Hospital's IRB

Keywords provided by Beijing YouAn Hospital:
Chinese medicines
Severe hand-foot-mouth diseases
effectiveness
safety

Additional relevant MeSH terms:
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 19, 2013