Trial | NCT01554930  Report issue

Title

Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease
A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    230
The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD).
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of a traditional Chinese medicine, Xiyanping injection,for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.
Study Started
May 31
2010
Primary Completion
Nov 30
2010
Study Completion
Dec 31
2011
Last Update
Mar 15
2012
Estimate

Drug Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)

Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.

Drug Xiyanping injection plus western therapy

Xiyanping injection:5-10mg/kg/d (0.2-0.4ml/kg/d),qd ivgtt; Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.

Western therapy Active Comparator

Xiyanping injection plus western therapy Experimental

Criteria 

Inclusion Criteria:

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 24 hours of occurrence of fever and/or occurrence of tetter or herpes.
Age of 1-13 years.
Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion Criteria:

Complicated with other diseases such as neurogenic pulmonary edema, cardiopulmonary failure.
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 who using glucocorticoids for based diseases.
Patients who having history of hemolysis.
Patients or their guardians suffering from Psychiatric diseases.
Attending other clinical studies on HFMD after diagnosed.
No Results Posted