Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study

Study Overview
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Brief Summary
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The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot, and mouth disease (HFMD).

Detailed Description
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By adopting a multicenter, prospective, randomized double-blind, placebo-controlled, this study is aimed to evaluate the effectiveness, safety of a traditional Chinese medicine, Jinlianqingre Effervescent Tablets, for treatment Uncomplicated 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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* Drug: Western therapy
* Drug: JET
* Drug: Placebo(for JET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of mild hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; Within 48 hours of onset of fever and rash symptom. Age of 1-13 years. Documented body temperature 37.4 °C-39.0°C Patients or their guardians agree to participate in this study and signed the informed consent form. Exclusion Criteria: Complicated with other serious diseases such as chronic hepatitis,chronic diarrhea disease,chronic diarrhea, congenital heart disease, acute or chronic nephritis and blood diseases. With history of allergies on traditional Chinese medicine. Attending other clinical studies on HFMD after diagnosed.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 13 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Western therapy & Placebo<br>Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets ) | Drug: Western therapy<br>* Physical cooling paste or warm bathing, vitamin B, vitamin C. On the basis of the attending physician's judgment, participants were allowed to use Ibuprofen suspension if their body temperature was greater than 38.5℃. Likewise, the need for antibiotics was determined by the attending physicians. The use of acetaminophen or antibiotics was recorded on the case record form<br>Drug: Placebo(for JET)<br>* placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)<br>|
| Experimental: Western therapy & JET<br>Jinlianqingre Effervescent Tablets plus western therapy | Drug: Western therapy<br>* Physical cooling paste or warm bathing, vitamin B, vitamin C. On the basis of the attending physician's judgment, participants were allowed to use Ibuprofen suspension if their body temperature was greater than 38.5℃. Likewise, the need for antibiotics was determined by the attending physicians. The use of acetaminophen or antibiotics was recorded on the case record form<br>Drug: JET<br>* 4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃)<br>* Other names: Jinlianqingre Effervescent Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of body temperature going back to normal | Referring 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 |
| --- | --- | --- |
| Healing time of skin or oral mucosa lesions symptom | Referring to the number of days in the total-contact cast until the skin completely closed after the medicine is used. | 10 days | 
| Score of skin or oral mucosa lesions symptom during the study period time | Referring to Symptoms were hands, feet, oral mucosa lesions, buttock, crissum, back and four limbs. Each symptom was scored as 0 (none), 1 (mild), 2 (modest), or 3 (severe). | 10 days | 
| the length of hospital stay |  | 10 days | 
| major complications rate | Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enterovirus, Hand, Foot and Mouth Disease, Medicine, Chinese Traditional, Fever