Clinical trial NCT02069665: Effectiveness Study of Integrative Treatment for Pediatric Pneumonia
Official title: Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by PRC National Clinical Research Base of Traditional Chinese Medicine for Major Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Keywords: pneumonia
pediatrics
viral
Lead sponsor: Liaoning University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
First posted: 2014-02-24
Enrollment: 451
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
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 retrospective case study has been finished at the National clinical research base of traditional Chinese medicine for major disease pediatric pneumonia, and the research center organized the field training of prospective-study to coordinated units. Based on the primary statistical outcomes of retrospective case study and the discussion around prospective-study during the training, investigators found it difficult to include simplex viral infection, therefore, investigators revised the inclusion criteria and treatment protocol of the pragmatic randomized controlled trial.

The block randomization is used in this trial. Random numbers are generated by SPSS software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 369, and considering drop-out or withdrawal, investigators plan to enroll 450 patients (300 in experimental group, 150 in control).

Eligibility criteria: Inclusion Criteria:

* children, aged 6 months to 59 months old, diagnosed as pneumonia according to western medicine diagnostic criteria;
* diagnosed as TCM pneumonia with gasp-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:

* emergency pneumonia;
* complicated with other Pulmonary Disorders attack other than pneumonia;
* complicated with primary disease of heart (congenital heart disease, myocarditis, et al), liver (ALT, and AST ≥ 1.5 times of normal value ceiling), kidney (BUN \> 8.2mmol/L, or serum CR \> 104 µmol/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.

Primary outcomes:
measure: Cured rate
timeFrame: Every day since receiving treatment, all together 10 days (times)
measure: Effectiveness time window
timeFrame: Every day since receiving treatment, all together 10 days (times)
Secondary outcomes:
measure: TCM syndrome scores and effective rate
timeFrame: 10 days
measure: Effect in fever, cough, phlegm and gasp
timeFrame: 10 days
measure: Time of lung rales disappear completely
timeFrame: 10 days
measure: Check-out time
timeFrame: 10 days
measure: Pulmonary disease incidence
timeFrame: 30 days
Other outcomes:
measure: Direct medical cost
timeFrame: observed during treatment in 10 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: 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
Study officials:
affiliation: Affiliated Hospital of Liaoning University of TCM
name: Xuefeng Wang, Ph.D.
role: STUDY_DIRECTOR
affiliation: Affiliated Hospital of Liaoning University of TCM
name: Zhenqi Wu
role: PRINCIPAL_INVESTIGATOR
References: