Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

N/ACompletedNCT02069665

Liaoning University of Traditional Chinese Medicine451 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

451

Conditions

Pneumonia

Interventions

Fuxiong SanOTHER

external application; 8-10cm wide, 0.3-0.5cm thick; 10mins for patient aged 1 to 3-year old; 15mins for those aged 3 to 5-year old; once daily

Xiyanping injectionDRUG

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

Ribavirin InjectionDRUG

ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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.

Locations (6)

Affiliated Children's Hospital of Capital University of Medical Sciences

Beijing, Beijing Municipality, China

Guangzhou Children's Hospital

Guangzhou, Guangdong, China

Affiliated Children's Hospital of Dalian Medical University

Dalian, Liaoning, China

Affiliated Hospital of Liaoning University of TCM

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

Cured rate

Clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded.

Time frame: Every day since receiving treatment, all together 10 days (times)

Effectiveness time window

days range from treatment is received to the effectiveness is observed, and symptoms disappear

Time frame: Every day since receiving treatment, all together 10 days (times)

Secondary Outcomes

TCM syndrome scores and effective rate

Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate

Time frame: 10 days

Effect in fever, cough, phlegm and gasp

temperature, fever frequency, fever lasting time, Ibuprofen Suspension dosing; cough severity; phlegm amount, color and nature; gasp frequency, severity, all to be measured

Time frame: 10 days

Time of lung rales disappear completely

days are counted since receiving treatment, when the chest radiograph returns to normal

Time frame: 10 days

Check-out time

days counted when the patient checks out

Time frame: 10 days

Pulmonary disease incidence

unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up

Time frame: 30 days

Data from ClinicalTrials.gov

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