Status:
COMPLETED
A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Lead Sponsor:
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Collaborating Sponsors:
Beijing University of Chinese Medicine
China Academy of Chinese Medical Sciences
Conditions:
Hand, Foot and Mouth Disease
Eligibility:
All Genders
1-14 years
Phase:
NA
Brief Summary
The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).
Detailed Description
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of traditional Chinese medicine for treatment of...
Eligibility Criteria
Inclusion
- 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; More than 1/3 patients should be diagnosed by etiological examination.
- Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes.
- Age of 1-14 years.
- Patients or their guardians agree to participate in this study and signed the informed consent form.
Exclusion
- Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
- With history of allergies on traditional Chinese medicine.
- Patients or their guardians suffering from Psychiatric diseases.
- Attending other clinical studies on HFMD after diagnosed.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT01182532
Start Date
May 1 2010
End Date
December 1 2011
Last Update
July 23 2012
Active Locations (21)
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1
Anhui Provincial Children's Hospital
Hefei, Anhui, China
2
The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
Hefei, Anhui, China
3
Beijing Ditan Hospital
Beijing, Beijing Municipality, China
4
Beijing You-An Hospital
Beijing, Beijing Municipality, China