Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia
NCT ID: NCT02362906
Last Updated: 2015-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1500 participants
INTERVENTIONAL
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Xiyanping injection
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
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
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
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
second generation cephalosporin
Erythromycin
ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
Azithromycin
ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
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.
Xiyanping injection
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
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
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
second generation cephalosporin
Erythromycin
ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
Azithromycin
ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
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.
Xiyanping injection
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
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
second generation cephalosporin
Erythromycin
ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
Azithromycin
ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
Interventions
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Xiyanping injection
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
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
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
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
second generation cephalosporin
Erythromycin
ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
Azithromycin
ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
14 Years
ALL
Yes
Sponsors
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Beijing University of Chinese Medicine
OTHER
Liaoning University of Traditional Chinese Medicine
OTHER
Responsible Party
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Xuefeng Wang
Chief physician
Locations
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Affiliated Children's Hospital of Capital University of Medical Sciences
Beijing, Beijing Municipality, China
Guangzhou Children's Hospital
Guangzhou, Guangdong, China
Affiliated hospital of Guangzhou university of Chinese Medicine
Guangzhou, Guangdong, China
Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China
Affiliated Hospital of Changchun University of TCM
Changchun, Jilin, China
Affiliated Children's Hospital of Dalian Medical University
Dalian, Liaoning, China
Affiliated Hospital of Liaoning University of TCM
Shenyang, Liaoning, China
Affiliated Hospital of Shandong University of TCM
Ji'nan, Shandong, China
Affiliated Longhua Hospital of Shanghai University of TCM
Shanghai, Shanghai Municipality, China
First teaching hospital of Tianjin university of TCM
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Xuefeng Wang, Ph.D
Role: CONTACT
Facility Contacts
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Kunling Shen, Ph. D
Role: primary
Li Deng, Master's
Role: primary
Hua Xu, Ph.D
Role: primary
Lining Wang, Ph.D
Role: primary
Xiaochun Feng, Ph.D
Role: primary
Zhenze Cui, Ph. D
Role: primary
Xuefeng Wang, Ph.D.
Role: primary
Yanning Li, Ph. D
Role: primary
Zhiyan Jiang, Bachelor's
Role: primary
Rong Ma, Ph.D
Role: primary
Other Identifiers
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201307007
Identifier Type: -
Identifier Source: org_study_id
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