Pneumonia
Conditions
Keywords
pneumonia, pediatrics, viral
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 retrospective case study has been finished at the National clinical research base of traditional Chinese medicine for major disease pediatric pneumonia, and the research center organized the field training of prospective-study to coordinated units. Based on the primary statistical outcomes of retrospective case study and the discussion around prospective-study during the training, investigators found it difficult to include simplex viral infection, therefore, investigators revised the inclusion criteria and treatment protocol of the pragmatic randomized controlled trial. The block randomization is used in this trial. Random numbers are generated by SPSS software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 369, and considering drop-out or withdrawal, investigators plan to enroll 450 patients (300 in experimental group, 150 in control).
Interventions
OTHERFuxiong San
external application; 8-10cm wide, 0.3-0.5cm thick; 10mins for patient aged 1 to 3-year old; 15mins for those aged 3 to 5-year old; once daily
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
DRUGRibavirin Injection
ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
DRUGXiaoer Qingfei Heji (mixture)
children aged 6 months to 1 year old: 10 ml, orally taken three times daily; children aged 1 to 3 year old: 15 ml, orally taken three times daily; children aged 3 to 5 year old: 20 ml, orally taken three times daily;
DRUGZhi Ke San
children aged 6 months to 1 year old: 0.5g, orally taken three times daily; children aged 1 to 3 year old: 1.5g, orally taken three times daily; children aged 3 to 5 year old: 2.0g, orally taken three times daily;
DRUGHua Tan San
children aged 6 months to 1 year old: 0.5g, orally taken three times daily; children aged 1 to 3 year old: 1.5g, orally taken three times daily; children aged 3 to 5 year old: 2.0g, orally taken three times daily;
children aged 6 months to 1 year old: 3ml, orally taken three times daily; children aged 1 to 3 year old: 5ml, orally taken three times daily; children aged 3 to 5 year old: 8ml, orally taken three times daily;
taken under prescription
DRUGsalbutamol
taken under prescription
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
6 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* children, aged 6 months to 59 months old, diagnosed as pneumonia according to western medicine diagnostic criteria; * diagnosed as TCM pneumonia with gasp-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
* emergency pneumonia; * complicated with other Pulmonary Disorders attack other than pneumonia; * complicated with primary disease of heart (congenital heart disease, myocarditis, et al), liver (ALT, and AST ≥ 1.5 times of normal value ceiling), kidney (BUN \> 8.2mmol/L, or serum CR \> 104 µmol/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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness time window | Every day since receiving treatment, all together 10 days (times) | days range from treatment is received to the effectiveness is observed, and symptoms disappear |
| Cured rate | Every day since receiving treatment, all together 10 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 fever, cough, phlegm and gasp | 10 days | temperature, fever frequency, fever lasting time, Ibuprofen Suspension dosing; cough severity; phlegm amount, color and nature; gasp frequency, severity, all to be measured |
| Time of lung rales disappear completely | 10 days | days are counted since receiving treatment, when the chest radiograph returns to normal |
| Pulmonary disease incidence | 30 days | unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up |
| Check-out time | 10 days | days counted when the patient checks out |
| TCM syndrome scores and effective rate | 10 days | Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Direct medical cost | observed during treatment in 10 days | Medical cost including hospital expenses, examine fee, medication fee, et al, related to treatment in hospital |
Countries
China
Outcome results
None listed