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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
288
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
4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃)
placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)
Tangshan infectious disease hospital
Tangshan, Hebei, China
Affiliated Hospital of Chengdu university of Traditional Chinese Medicine
Chengdu, Sichuan, China
Beijing children's hospital
Beijing, China
Tianjin infectious disease hospital
Tianjin, China
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.
Time frame: 10 days
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.
Time frame: 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).
Time frame: 10 days
the length of hospital stay
Time frame: 10 days
major complications rate
Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al.
Time frame: 10 days
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