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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Hand, Foot and Mouth Disease

Intervention / Treatment
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* Other: Western therapy
* Drug: TCM Syndrome Differentiation and Treatment
* Other: Western therapy plus TCM treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Western therapy<br> | Other: Western therapy<br>* 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;<br>|
| Experimental: TCM treatment<br> | Drug: TCM Syndrome Differentiation and Treatment<br>* 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.<br>|
| Experimental: Western therapy plus TCM treatment<br>The combination of both western therapy and TCM treatment. | Other: Western therapy plus TCM treatment<br>* Symptomatic treatment using the same treatment methods in western therapy group; Syndrome differentiation and treatment adopting the same methods in TCM treatment group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to onset | Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken. | 10 days | 
| time of body temperature going back to normal | 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. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of symptom disappearance | Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used. | 10 days | 
| case severity rate | 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. | 10 days | 
| time of tetter and oral ulcer disappearance | 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. | 10 days | 
| direct medical cost | Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc. | 10 days | 
| safety outcome | Calculated by adverse event. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild type of hand, foot and mouth disease, Traditional Chinese Medicine, Effectiveness, Safety