Trial | NCT01182532  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    3000
The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment 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 traditional Chinese medicine 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
Oct 31
2011
Study Completion
Dec 31
2011
Last Update
Jul 23
2012
Estimate

Other Western therapy

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;

Drug TCM Syndrome Differentiation and Treatment

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.

Other Western therapy plus TCM treatment

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

Western therapy Active Comparator

TCM treatment Experimental

Western therapy plus TCM treatment Experimental

The combination of both western therapy and TCM treatment.

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 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.
No Results Posted