Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by the Special Scientific Research Fund of Public Welfare Profession of China

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).

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.