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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Beijing YouAn Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01145664
First Posted: June 17, 2010
Last Update Posted: June 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
June 16, 2010
June 17, 2010
June 17, 2010
May 2010
August 2010   (Final data collection date for primary outcome measure)
  • incidence of complications [ Time Frame: 15 days ]
  • incidence of critically ill patients [ Time Frame: 15 days ]
Same as current
No Changes Posted
  • case fatality rate [ Time Frame: 15 days ]
  • time of symptom disappearance [ Time Frame: 15 days ]
  • time of bringing down a fever [ Time Frame: 15 days ]
  • length of stay [ Time Frame: 15 days ]
  • dose and usage of hormones [ Time Frame: 15 days ]
  • safety outcome(adverse effects) [ Time Frame: 15 days ]
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
Intervention Model: Parallel Assignment
Masking: None (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
Li XH, Li SJ, Xu Y, Wei D, Shi QS, Zhu QX, Yang T, Ding JB, Tian YM, Huang JH, Wang K, Wen T, Zhang X. Effect of integrated Chinese and Western medicine therapy on severe hand, foot and mouth disease: A prospective, randomized, controlled trial. Chin J Integr Med. 2016 Jul 9. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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
Sexes Eligible for Study: All
1 Year to 13 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01145664
200907001-3
Yes
Not Provided
Not Provided
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