The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,000
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;
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.
Anhui Provincial Children's Hospital
Hefei, Anhui, China
time to onset
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
Time frame: 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.
Time frame: 10 days
time of symptom disappearance
Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 days
safety outcome
Calculated by adverse event.
Time frame: 10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
Hefei, Anhui, China
Beijing Ditan Hospital
Beijing, Beijing Municipality, China
Beijing You-An Hospital
Beijing, Beijing Municipality, China
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
Fuzhou Infectious Disease Hospital
Fuzhou, Fujian, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
First Hospital of Lanzhou University
Lanzhou, Gausu, China
Shenzhen Third People's Hospital
Shenzhen, Guangzhou, China
The Fifth Hospital of Shijiazhuang, Hebei
Shijiazhuang, Hebei, China
...and 11 more locations