Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

Liaoning University of Traditional Chinese Medicine

Status

Unknown

Conditions

Pneumonia

Treatments

Drug: phlegm-heat formula granules

Drug: wind-heat formula granules

Drug: Azithromycin

Drug: second generation cephalosporin

Drug: Fu-xiong San

Drug: Xiyanping injection

Drug: Erythromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT02362906

201307007

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,500 estimated patients

Sex

All

Ages

1 to 14 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,500 participants in 3 patient groups

Injection,medications and application

Experimental group

Description:

Intravenous injection: bacterial pneumonia: second generation cephalosporin; mycoplasma pneumonia: erythromycin or azithromycin; viral pneumonia: Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co.,Ltd; Medications: according to TCM syndrome differentiations; Wind-heat blocking lungs pattern(feng re bi fei zheng): wind-heat formula granules; phlegm-heat blocking lungs pattern(tan re bi fei zheng): phlegm-heat formula granules; external application: Fu-xiong San.

Treatment:

Drug: Erythromycin

Drug: Fu-xiong San

Drug: Azithromycin

Drug: wind-heat formula granules

Drug: Xiyanping injection

Drug: second generation cephalosporin

Drug: phlegm-heat formula granules

Injection and medications

Experimental group

Description:

Intravenous injection: bacterial pneumonia：second generation cephalosporin; mycoplasma pneumonia：erythromycin or azithromycin; viral pneumonia：Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co.,Ltd; Medications: according to TCM syndrome differentiations; Wind-heat blocking lungs pattern(feng re bi fei zheng): wind-heat formula granules; phlegm-heat blocking lungs pattern(tan re bi fei zheng): phlegm-heat formula granules.

Treatment:

Drug: Erythromycin

Drug: Azithromycin

Drug: wind-heat formula granules

Drug: Xiyanping injection

Drug: second generation cephalosporin

Drug: phlegm-heat formula granules

Injection and application

Experimental group

Description:

Treatment:

Drug: Erythromycin