Pneumonia Clinical Trial
Official title:
Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by PRC National Clinical Research Base of Traditional Chinese Medicine for Major Diseases
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.
Status | Completed |
Enrollment | 451 |
Est. completion date | August 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 59 Months |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Affiliated Children's Hospital of Capital University of Medical Sciences | Beijing | Beijing |
China | Affiliated Children's Hospital of Dalian Medical University | Dalian | Liaoning |
China | Guangzhou Children's Hospital | Guangzhou | Guangdong |
China | Affiliated Hospital of Shandong University of TCM | Ji'nan | Shandong |
China | Affiliated Longhua Hospital of Shanghai University of TCM | Shanghai | Shanghai |
China | Affiliated Hospital of Liaoning University of TCM | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Liaoning University of Traditional Chinese Medicine | Beijing University of Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Direct medical cost | Medical cost including hospital expenses, examine fee, medication fee, et al, related to treatment in hospital | observed during treatment in 10 days | No |
Primary | 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 10 days (times) | No |
Primary | Effectiveness time window | days range from treatment is received to the effectiveness is observed, and symptoms disappear | Every day since receiving treatment, all together 10 days (times) | No |
Secondary | TCM syndrome scores and effective rate | Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate | 10 days | No |
Secondary | Effect in fever, cough, phlegm and gasp | temperature, fever frequency, fever lasting time, Ibuprofen Suspension dosing; cough severity; phlegm amount, color and nature; gasp frequency, severity, all to be measured | 10 days | No |
Secondary | Time of lung rales disappear completely | days are counted since receiving treatment, when the chest radiograph returns to normal | 10 days | No |
Secondary | Check-out time | days counted when the patient checks out | 10 days | No |
Secondary | Pulmonary disease incidence | unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up | 30 days | No |
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