Hand, Foot and Mouth Disease
Conditions
Keywords
Hand, Foot and Mouth Disease, Medicine, Chinese Traditional, Enterovirus, Fever
Brief summary
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
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.
Interventions
DRUGWestern therapy
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
DRUGJET
4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃)
DRUGPlacebo(for JET)
placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)
Sponsors
Chengdu University of Traditional Chinese Medicine
Beijing Children's Hospital
Tianjin infectious disease hospital
Tangshan infectious disease hospital
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.
China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time of body temperature going back to normal | 10 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing time of skin or oral mucosa lesions symptom | 10 days | Referring to the number of days in the total-contact cast until the skin completely closed after the medicine is used. |
| Score of skin or oral mucosa lesions symptom during the study period time | 10 days | 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). |
| the length of hospital stay | 10 days | — |
| major complications rate | 10 days | Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al. |
Countries
China
Outcome results
None listed