Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Pneumonia

Intervention / Treatment
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* Other: Fuxiong San
* Drug: Xiyanping injection
* Drug: Ribavirin Injection
* Drug: Xiaoer Qingfei Heji (mixture)
* Drug: Zhi Ke San
* Drug: Hua Tan San
* Drug: Guaifenesin Syrup
* Drug: Ibuprofen Suspension
* Drug: salbutamol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection, medications and application<br>Intravenous injection: 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): Xiaoer Qingfei Heji (mixture), and Zhi Ke San (herbal powder to relieve cough) Phlegm-heat blocking lungs pattern (tan re bi fei zheng): Xiaoer Qingfei Heji (mixture), and Hua Tan San (herbal powder to remove phlegm) External application: Fuxiong San | Other: Fuxiong San<br>* 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<br>Drug: Xiyanping injection<br>* ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.<br>Drug: Xiaoer Qingfei Heji (mixture)<br>* children aged 6 months to 1 year old: 10 ml, orally taken three times daily; children aged 1 to 3 year old: 15 ml, orally taken three times daily; children aged 3 to 5 year old: 20 ml, orally taken three times daily;<br>Drug: Zhi Ke San<br>* children aged 6 months to 1 year old: 0.5g, orally taken three times daily; children aged 1 to 3 year old: 1.5g, orally taken three times daily; children aged 3 to 5 year old: 2.0g, orally taken three times daily;<br>* Other names: herbal powder to relieve cough;Drug: Hua Tan San<br>* children aged 6 months to 1 year old: 0.5g, orally taken three times daily; children aged 1 to 3 year old: 1.5g, orally taken three times daily; children aged 3 to 5 year old: 2.0g, orally taken three times daily;<br>* Other names: herbal powder to remove phlegm;|
| Active Comparator: Injection and medications<br>Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; Ibuprofen Suspension, and salbutamol in case of different symptoms | Drug: Ribavirin Injection<br>* ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.<br>Drug: Guaifenesin Syrup<br>* children aged 6 months to 1 year old: 3ml, orally taken three times daily; children aged 1 to 3 year old: 5ml, orally taken three times daily; children aged 3 to 5 year old: 8ml, orally taken three times daily;<br>* Other names: Guaifenesin, Methylephedrine and Chlorphenamine Syrup;Drug: Ibuprofen Suspension<br>* taken under prescription<br>* Other names: Motrin;Drug: salbutamol<br>* taken under prescription<br>* Other names: β2-agonists;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cured rate | Clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded. | 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 | Every day since receiving treatment, all together 10 days (times) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TCM syndrome scores and effective rate | Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate | 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 | 10 days | 
| Time of lung rales disappear completely | days are counted since receiving treatment, when the chest radiograph returns to normal | 10 days | 
| Check-out time | days counted when the patient checks out | 10 days | 
| Pulmonary disease incidence | unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, pediatrics, viral