Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

Sponsor

Liaoning University of Traditional Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02362906

Collaborator

Beijing University of Chinese Medicine (Other)

1,500

Enrollment

Locations

Arms

150

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: Xiyanping injection Drug: wind-heat formula granules Drug: phlegm-heat formula granules Drug: Fu-xiong San Drug: second generation cephalosporin Drug: Erythromycin Drug: Azithromycin	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Injection,medications and application 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.	Drug: Xiyanping injection ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection Drug: wind-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 Drug: phlegm-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 Drug: Fu-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 Drug: second generation cephalosporin Drug: Erythromycin ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection Drug: Azithromycin ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
Experimental: Injection and medications 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.	Drug: Xiyanping injection ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection Drug: wind-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 Drug: phlegm-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 Drug: second generation cephalosporin Drug: Erythromycin ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection Drug: Azithromycin ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
Experimental: Injection and application Intravenous injection: bacterial pneumonia: second generation cephalosporin; mycoplasma pneumonia: erythromycin or azithromycin; viral pneumonia: Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co.,Ltd; external application: Fu-xiong San.	Drug: Xiyanping injection ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection Drug: Fu-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 Drug: second generation cephalosporin Drug: Erythromycin ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection Drug: Azithromycin ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection

Arm

Intervention/Treatment

Experimental: Injection,medications and application

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.

Drug: Xiyanping injection

ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection

Drug: wind-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

Drug: phlegm-heat formula granules

Drug: Fu-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

Drug: second generation cephalosporin

Drug: Erythromycin

ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection

Drug: Azithromycin

ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection

Experimental: Injection and medications

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.

Drug: Xiyanping injection

ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection

Drug: wind-heat formula granules

Drug: phlegm-heat formula granules

Drug: second generation cephalosporin

Drug: Erythromycin

ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection

Drug: Azithromycin

ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection

Experimental: Injection and application

Drug: Xiyanping injection

ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection

Drug: Fu-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

Drug: second generation cephalosporin

Drug: Erythromycin

ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection

Drug: Azithromycin

ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

effect in treating fever [7 days]
temperature, fever frequency,fever lasting time, Ibuprofen Suspension， all to be measured
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]
TCM syndrome scores [7 days]
measure is a composite.
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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 14 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Children's Hospital of Capital University of Medical Sciences	Beijing	Beijing	China	100045
2	Guangzhou Children's Hospital	Guangzhou	Guangdong	China	510120
3	Affiliated hospital of Guangzhou university of Chinese Medicine	Guangzhou	Guangdong	China	510405
4	Affiliated Hospital of Guangxi University of Chinese Medicine	Nanning	Guangxi	China	530023
5	Affiliated Hospital of Changchun University of TCM	Changchun	Jilin	China	130103
6	Affiliated Children's Hospital of Dalian Medical University	Dalian	Liaoning	China	116044
7	Affiliated Hospital of Liaoning University of TCM	Shenyang	Liaoning	China	110032
8	Affiliated Hospital of Shandong University of TCM	Ji'nan	Shandong	China	250011
9	Affiliated Longhua Hospital of Shanghai University of TCM	Shanghai	Shanghai	China	200032
10	First teaching hospital of Tianjin university of TCM	Tianjin	Tianjin	China	300193