Hand, Foot and Mouth Disease
Conditions
Keywords
Mild type of hand, foot and mouth disease, Traditional Chinese Medicine, Effectiveness, Safety
Brief summary
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
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.
Interventions
OTHERWestern therapy
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care. 1. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius; 2. Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;
DRUGTCM Syndrome Differentiation and Treatment
1. 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. 2. 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.
OTHERWestern therapy plus TCM treatment
1. Symptomatic treatment using the same treatment methods in western therapy group; 2. Syndrome differentiation and treatment adopting the same methods in TCM treatment group.
Sponsors
Beijing University of Chinese Medicine
China Academy of Chinese Medical Sciences
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to onset | 10 days | Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken. |
| time of body temperature going back to normal | 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
| Measure | Time frame | Description |
|---|---|---|
| time of tetter and oral ulcer disappearance | 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. |
| time of symptom disappearance | 10 days | Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used. |
| safety outcome | 10 days | Calculated by adverse event. |
| direct medical cost | 10 days | Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc. |
| case severity rate | 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. |
Countries
China
Outcome results
None listed