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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

Tracking Information
First Submitted Date  ICMJE June 16, 2010
First Posted Date  ICMJE June 17, 2010
Last Update Posted Date June 17, 2010
Study 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 ]
  • incidence of critically ill patients [ Time Frame: 15 days ]
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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Arms  ICMJE
  • 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 * 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. 2017 Dec;23(12):887-892. doi: 10.1007/s11655-016-2504-3. Epub 2016 Jul 9.

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 16, 2010)
390
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01145664
Other Study ID Numbers  ICMJE 200907001-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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