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NCT Number: NCT01182532

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

The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).

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Key information

Conditions

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

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anhui Provincial Children's Hospital, Hefei, Anhui, 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 traditional Chinese medicine 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 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 criteria

  • 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.

Treatment and study plan

Western therapy

Other

Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.

  • Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;
  • Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;

TCM Syndrome Differentiation and Treatment

Drug
  • Lung-Spleen Damp-Heat Syndrome Symptoms: Fever, maculopapule and herpes on hand, foot and buttock; herpes on oral mucous membrane; redness in throat, salivation, tiredness, faint red tongue or reddish tongue, greasy fur, speedy pulse, red and purple fingerprint.

Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Lonicera japonica Thunb (Jin Yin Hua), Scutellaria baicalensis Georgi (Huang Qin), etc.

Dosage: Adjusting by age and weight of patients. Decoction.

  • Dampness-Heat Retention Syndrome Symptoms: High fever, dirty color of tetter, tiredness, oral ulcer, reddish tongue or deep red tongue, little saliva, yellow and greasy fur, fine and rapid pulse, deep purple fingerprint.

Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Gardenia jasminoides Ellis (rough Zhi Zi), Scutellaria baicalensis Georgi (Huang Qin), etc.

Dosage: Adjusting by age and weight of patients. Decoction.

Western therapy plus TCM treatment

Other
  • Symptomatic treatment using the same treatment methods in western therapy group;
  • Syndrome differentiation and treatment adopting the same methods in TCM treatment group.

Primary outcomes

  1. time to onset

    Time frame: 10 days

    Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.

  2. time of body temperature going back to normal

    Time frame: 10 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.

Secondary outcomes

  1. time of symptom disappearance

    Time frame: 10 days

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

  2. case severity rate

    Time frame: 10 days

    Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc.

  3. time of tetter and oral ulcer disappearance

    Time frame: 10 days

    Refering to the length of time when the tetter due to HFMD disappears, characterised by no new tetter and oral ulcer develops, scab(s) or dropping; and time of oral ulcer concrescence, etc.

  4. direct medical cost

    Time frame: 10 days

    Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.

  5. safety outcome

    Time frame: 10 days

    Calculated by adverse event.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Other

Collaborators

  • Beijing University of Chinese Medicine
  • China Academy of Chinese Medical Sciences

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 17, 2010
Registry last updated
Jul 23, 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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