Effectiveness Study of Integrative Treatment for Pediatric Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

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).
    

Intervention name(s): Fuxiong San; Xiyanping injection; Ribavirin Injection; Xiaoer Qingfei Heji (mixture); Zhi Ke San; Hua Tan San; Guaifenesin Syrup; Ibuprofen Suspension; salbutamol
Intervention type(s): Other; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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; ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.; ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.; 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;; 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;; 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;; 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;; taken under prescription; taken under prescription
Other intervention name(s): herbal powder to relieve cough; herbal powder to remove phlegm; Guaifenesin, Methylephedrine and Chlorphenamine Syrup; Motrin; β2-agonists
Intervention MeSH terms: Ribavirin; Ibuprofen; Phenylpropanolamine; Albuterol; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pneumonia; pediatrics; viral