The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.
The block randomization is used in this trial. Random numbers are generated by statistical analysis system(SAS) software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 1164 , and considering drop-out or withdrawal, investigators plan to enroll 1500 patients (500 in experimental group 1, 500 in experimental group 2, 500 in experimental group 3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,500
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
children aged 6 months to 3-year old: 1/2 packet,orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet,orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet, orally taken two times daily or frequency
children aged 6 months to 3-year old: 1/2 packet,orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet,orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet, orally taken two times daily or frequency
Affiliated Children's Hospital of Capital University of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGGuangzhou Children's Hospital
Guangzhou, Guangdong, China
Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded)
clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded
Time frame: every day since receiving treatment,all together 7 days (times)
effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear)
days range from treatment is received to the effectiveness is observed, and symptoms disappear
Time frame: every day since receiving treatment, all together 7 days (times)
effect in treating fever
temperature, fever frequency,fever lasting time, Ibuprofen Suspension, all to be measured
Time frame: 7 days
effect in dyspnea releasing
gasp frequency, severity, all to be measured
Time frame: 7 days
effect in phlegm releasing
phlegm amount,color and nature to be measured
Time frame: 7 days
effect in cough releasing
cough severity to be measured
Time frame: 7 days
time from admission to recovery of rales
Time frame: 7 days
TCM syndrome scores
measure is a composite.
Time frame: 7 days
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external application; 8-10 cm wide, 0.3-0.5 cm thick;10 mins for patient aged 1 to 3-year old; 15 mins for those aged 3 to 5-year old; once daily
ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
Affiliated hospital of Guangzhou university of Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGAffiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China
RECRUITINGAffiliated Hospital of Changchun University of TCM
Changchun, Jilin, China
RECRUITINGAffiliated Children's Hospital of Dalian Medical University
Dalian, Liaoning, China
RECRUITINGAffiliated Hospital of Liaoning University of TCM
Shenyang, Liaoning, China
RECRUITINGAffiliated Hospital of Shandong University of TCM
Ji'nan, Shandong, China
RECRUITINGAffiliated Longhua Hospital of Shanghai University of TCM
Shanghai, Shanghai Municipality, China
RECRUITINGFirst teaching hospital of Tianjin university of TCM
Tianjin, Tianjin Municipality, China
RECRUITINGeffective rate of TCM syndrome scores
total effecive rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate
Time frame: 7 days
check-out time (days counted when the patient checks out)
days counted when the patient checks out
Time frame: 7 days
pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up)
prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up
Time frame: 15 days; 30 days; 90 days
safety (With adverse events as the calculation basis)
With adverse events as the calculation basis
Time frame: 7 days