Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2015

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).

Interventions

  • Drug: Xiyanping injection
    • ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
  • Drug: wind-heat formula granules
    • children aged 6 months to 3-year old: 1/2 packet,orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet,orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet, orally taken two times daily or frequency
  • Drug: phlegm-heat formula granules
    • children aged 6 months to 3-year old: 1/2 packet,orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet,orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet, orally taken two times daily or frequency
  • Drug: Fu-xiong San
    • external application; 8-10 cm wide, 0.3-0.5 cm thick;10 mins for patient aged 1 to 3-year old; 15 mins for those aged 3 to 5-year old; once daily
  • Drug: second generation cephalosporin
  • Drug: Erythromycin
    • ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
  • Drug: Azithromycin
    • ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection

Arms, Groups and Cohorts

  • Experimental: Injection,medications and application
    • Intravenous injection: bacterial pneumonia: second generation cephalosporin; mycoplasma pneumonia: erythromycin or azithromycin; viral pneumonia: 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): wind-heat formula granules; phlegm-heat blocking lungs pattern(tan re bi fei zheng): phlegm-heat formula granules; external application: Fu-xiong San.
  • Experimental: Injection and medications
    • Intravenous injection: bacterial pneumonia:second generation cephalosporin; mycoplasma pneumonia:erythromycin or azithromycin; viral pneumonia: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): wind-heat formula granules; phlegm-heat blocking lungs pattern(tan re bi fei zheng): phlegm-heat formula granules.
  • Experimental: Injection and application
    • Intravenous injection: bacterial pneumonia: second generation cephalosporin; mycoplasma pneumonia: erythromycin or azithromycin; viral pneumonia: Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co.,Ltd; external application: Fu-xiong San.

Clinical Trial Outcome Measures

Primary Measures

  • 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 7 days (times)
    • clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded
  • effective 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 7 days (times)
    • days range from treatment is received to the effectiveness is observed, and symptoms disappear

Secondary Measures

  • effect in treating fever
    • Time Frame: 7 days
    • temperature, fever frequency,fever lasting time, Ibuprofen Suspension, all to be measured
  • effect in dyspnea releasing
    • Time Frame: 7 days
    • gasp frequency, severity, all to be measured
  • effect in phlegm releasing
    • Time Frame: 7 days
    • phlegm amount,color and nature to be measured
  • effect in cough releasing
    • Time Frame: 7 days
    • cough severity to be measured
  • time from admission to recovery of rales
    • Time Frame: 7 days
  • TCM syndrome scores
    • Time Frame: 7 days
    • measure is a composite.
  • effective rate of TCM syndrome scores
    • Time Frame: 7 days
    • total effecive rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate
  • check-out time (days counted when the patient checks out)
    • Time Frame: 7 days
    • days counted when the patient checks out
  • pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up)
    • Time Frame: 15 days; 30 days; 90 days
    • prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up
  • safety (With adverse events as the calculation basis)
    • Time Frame: 7 days
    • With adverse events as the calculation basis

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Liaoning University of Traditional Chinese Medicine
  • Collaborator
    • Beijing University of Chinese Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xuefeng Wang, Chief physician – Liaoning University of Traditional Chinese Medicine
  • Overall Contact(s)
    • Xuefeng Wang, Ph.D, 13840208807

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