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
1 other identifier
interventional
1,500
1 country
10
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for not_applicable
10 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 22, 2015
CompletedFirst Posted
Study publicly available on registry
February 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedFebruary 13, 2015
February 1, 2015
1.3 years
January 22, 2015
February 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded)
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)
effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear)
days range from treatment is received to the effectiveness is observed, and symptoms disappear
every day since receiving treatment, all together 7 days (times)
Secondary Outcomes (10)
effect in treating fever
7 days
effect in dyspnea releasing
7 days
effect in phlegm releasing
7 days
effect in cough releasing
7 days
time from admission to recovery of rales
7 days
- +5 more secondary outcomes
Other Outcomes (1)
direct medical cost
observed during treatment in 7 days
Study Arms (3)
Injection,medications and application
EXPERIMENTALIntravenous 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.
Injection and medications
EXPERIMENTALIntravenous 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.
Injection and application
EXPERIMENTALIntravenous 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.
Interventions
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
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
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
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
ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Affiliated Children's Hospital of Capital University of Medical Sciences
Beijing, Beijing Municipality, 100045, China
Guangzhou Children's Hospital
Guangzhou, Guangdong, 510120, China
Affiliated hospital of Guangzhou university of Chinese Medicine
Guangzhou, Guangdong, 510405, China
Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, 530023, China
Affiliated Hospital of Changchun University of TCM
Changchun, Jilin, 130103, China
Affiliated Children's Hospital of Dalian Medical University
Dalian, Liaoning, 116044, China
Affiliated Hospital of Liaoning University of TCM
Shenyang, Liaoning, 110032, China
Affiliated Hospital of Shandong University of TCM
Ji'nan, Shandong, 250011, China
Affiliated Longhua Hospital of Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032, China
First teaching hospital of Tianjin university of TCM
Tianjin, Tianjin Municipality, 300193, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
January 22, 2015
First Posted
February 13, 2015
Study Start
April 1, 2014
Primary Completion
August 1, 2015
Last Updated
February 13, 2015
Record last verified: 2015-02