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NCT Number: NCT01554930

Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease

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).

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Key information

Conditions

Hand, Foot, and Mouth Disease Coxsackievirus Infections Enterovirus Infections Hand, Foot and Mouth Disease Infections Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liuzhou People's Hospital, Liuzhou, Guangxi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)

Drug

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

Xiyanping injection plus western therapy

Drug

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.

Primary outcomes

  1. complication rate

    Time frame: 15 days

    Refering to the ratio of patient having complications such as pulmonary edema, myocarditis，damage of central nervous system，shock, respiratory failure, multiple organ failur etc.

Secondary outcomes

  1. time of body temperature going back to normal

    Time frame: 15 days

    Refering to the time of the armpit temperature of lower than 37.0 degrees Celsius, lasting for at least 24 hours, after the medicine is taken.

  2. time of symptom disappearance

    Time frame: 15 days

    Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.

  3. safety outcome

    Time frame: 15 days

    Calculated by adverse event

Sponsors and collaborators

Lead sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Industry

Collaborators

  • Beijing University of Chinese Medicine
  • Beijing YouAn Hospital
  • China Academy of Chinese Medical Sciences
  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 15, 2012
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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