Pneumonia
Conditions
Keywords
pneumonia, pediatrics
Brief summary
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.
Detailed description
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).
Interventions
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
DRUGwind-heat formula granules
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
DRUGphlegm-heat formula granules
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
DRUGFu-xiong San
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
DRUGsecond generation cephalosporin
DRUGErythromycin
ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
DRUGAzithromycin
ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
Sponsors
Beijing University of Chinese Medicine
Liaoning University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* children,aged 1 to 14 years old; * diagnosed as pneumonia according to western medicine diagnostic criteria; * diagnosed as TCM pneumonia with pneumonia with dyspnea and cough, meeting wind-heat blocking lungs pattern (feng re bi fei zheng), and phlegm-heat blocking lungs pattern(tan re bi fei zheng); * disease progression within 72 hours; those whose guardians understood and assigned the informed consent;
Exclusion criteria
* severe pneumonia; * complicated with other Pulmonary Disorders attack other than pneumonia; * complicated with primary disease of heart(congenital heart disease, myocarditis, et al),liver(alanine aminotransferase(ALT),and aspartate transaminase(AST) ≥1.5 times of normal value ceiling),kidney (blood urea nitrogen(BUN) \>8.2mmol/l, or serum C reactive protein \>104umol/l,et al) and blood system (anemia) ,and those with psychopathy; * allergic to interventional medications; those who are participating or have participated in other clinical trials in 3 months; * those who intend to lost follow-up by practitioners' judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear) | every day since receiving treatment, all together 7 days (times) | days range from treatment is received to the effectiveness is observed, and symptoms disappear |
| Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded) | every day since receiving treatment,all together 7 days (times) | clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effect in dyspnea releasing | 7 days | gasp frequency, severity, all to be measured |
| effect in phlegm releasing | 7 days | phlegm amount,color and nature to be measured |
| effect in cough releasing | 7 days | cough severity to be measured |
| time from admission to recovery of rales | 7 days | — |
| effective rate of TCM syndrome scores | 7 days | total effecive rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate |
| check-out time (days counted when the patient checks out) | 7 days | days counted when the patient checks out |
| pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up) | 15 days; 30 days; 90 days | prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up |
| safety (With adverse events as the calculation basis) | 7 days | With adverse events as the calculation basis |
| TCM syndrome scores | 7 days | measure is a composite. |
| effect in treating fever | 7 days | temperature, fever frequency,fever lasting time, Ibuprofen Suspension， all to be measured |
Other
| Measure | Time frame | Description |
|---|---|---|
| direct medical cost | observed during treatment in 7 days | medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital |
Countries
China
Contacts
Primary ContactXuefeng Wang, Ph.D
Outcome results
None listed