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

June 16, 2010
June 16, 2010
May 2010
August 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
Not Provided

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hand, Foot and Mouth Disease
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
390
Not Provided
August 2010   (final data collection date for primary outcome measure)

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
Both
1 Year to 13 Years
No
Not Provided
China
 
NCT01145664
200907001-3
Yes
Xiuhui Li, Beijing YouAn Hospital,Capital Medical University
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
Not Provided
Beijing YouAn Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP