Clinical trial NCT02362906: Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia
Keywords: pneumonia
pediatrics
Lead sponsor: Liaoning University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
First posted: 2015-02-13
Enrollment: 1500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded)
timeFrame: every day since receiving treatment,all together 7 days (times)
measure: effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear)
timeFrame: every day since receiving treatment, all together 7 days (times)
Secondary outcomes:
measure: effect in treating fever
timeFrame: 7 days
measure: effect in dyspnea releasing
timeFrame: 7 days
measure: effect in phlegm releasing
timeFrame: 7 days
measure: effect in cough releasing
timeFrame: 7 days
measure: time from admission to recovery of rales
timeFrame: 7 days
measure: TCM syndrome scores
timeFrame: 7 days
measure: effective rate of TCM syndrome scores
timeFrame: 7 days
measure: check-out time (days counted when the patient checks out)
timeFrame: 7 days
measure: pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up)
timeFrame: 15 days; 30 days; 90 days
measure: safety (With adverse events as the calculation basis)
timeFrame: 7 days
Other outcomes:
measure: direct medical cost
timeFrame: observed during treatment in 7 days
Locations:
city: Beijing
country: China
facility: Affiliated Children's Hospital of Capital University of Medical Sciences
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Children's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Affiliated hospital of Guangzhou university of Chinese Medicine
state: Guangdong
city: Nanning
country: China
facility: Affiliated Hospital of Guangxi University of Chinese Medicine
state: Guangxi
city: Changchun
country: China
facility: Affiliated Hospital of Changchun University of TCM
state: Jilin
city: Dalian
country: China
facility: Affiliated Children's Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Affiliated Hospital of Liaoning University of TCM
state: Liaoning
city: Ji'nan
country: China
facility: Affiliated Hospital of Shandong University of TCM
state: Shandong
city: Shanghai
country: China
facility: Affiliated Longhua Hospital of Shanghai University of TCM
state: Shanghai
city: Tianjin
country: China
facility: First teaching hospital of Tianjin university of TCM
state: Tianjin
Study officials:
References: