Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumonia
• Intervention / Treatment: Drug: Xiyanping injection; Drug: wind-heat formula granules; Drug: phlegm-heat formula granules; Drug: Fu-xiong San; Drug: second generation cephalosporin; Drug: Erythromycin; Drug: Azithromycin

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).

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Recruiting
      • Affiliated Children's Hospital of Capital University of Medical Sciences
      • Contact: Kunling Shen, Ph. D; Phone Number: 0086-13910727586
      • Principal Investigator: Kunling Shen, Ph. D
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangzhou Children's Hospital
      • Contact: Li Deng, Master's; Phone Number: 0086-13711220382
      • Principal Investigator: Li Deng, Master's
    • Guangzhou, Guangdong, China, 510405
      • Recruiting
      • Affiliated hospital of Guangzhou university of Chinese Medicine
      • Contact: Hua Xu, Ph.D; Phone Number: 13724885258
  • Guangxi
    • Nanning, Guangxi, China, 530023
      • Recruiting
      • Affiliated Hospital of Guangxi University of Chinese Medicine
      • Contact: Lining Wang, Ph.D; Phone Number: 13607717743
  • Jilin
    • Changchun, Jilin, China, 130103
      • Recruiting
      • Affiliated Hospital of Changchun University of TCM
      • Contact: Xiaochun Feng, Ph.D; Phone Number: 13578696998
  • Liaoning
    • Dalian, Liaoning, China, 116044
      • Recruiting
      • Affiliated Children's Hospital of Dalian Medical University
      • Contact: Zhenze Cui, Ph. D; Phone Number: 0086-13904084058
      • Principal Investigator: Zhenze Cui, Ph. D
    • Shenyang, Liaoning, China, 110032
      • Recruiting
      • Affiliated Hospital of Liaoning University of TCM
      • Contact: Xuefeng Wang, Ph.D.; Phone Number: 0086-13840208807
      • Principal Investigator: Xuefeng Wang, Ph. D
  • Shandong
    • Ji'nan, Shandong, China, 250011
      • Recruiting
      • Affiliated Hospital of Shandong University of TCM
      • Contact: Yanning Li, Ph. D; Phone Number: 0086-13905313077
      • Principal Investigator: Yanning Li, Ph. D
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Affiliated Longhua Hospital of Shanghai University of TCM
      • Contact: Zhiyan Jiang, Bachelor's; Phone Number: 0086-13801868578
      • Principal Investigator: Zhiyan Jiang, Bachelor's
  • Tianjin
    • Tianjin, Tianjin, China, 300193
      • Recruiting
      • First Teaching Hospital of Tianjin University of TCM
      • Contact: Rong Ma, Ph.D; Phone Number: 13902095399

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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.	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: 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
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.	Drug: Xiyanping injection; ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection; 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

What is the study measuring?

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)	clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded	every day since receiving treatment,all together 7 days (times)
effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear)	days range from treatment is received to the effectiveness is observed, and symptoms disappear	every day since receiving treatment, all together 7 days (times)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
direct medical cost	medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital	observed during treatment in 7 days

Collaborators and Investigators

• Sponsor: Liaoning University of Traditional Chinese Medicine
• Collaborators: Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 13, 2015

Study Record Updates

• Last Update Posted (Estimate): February 13, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: pediatrics; pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Azithromycin; Cephalosporins
• Other Study ID Numbers: 201307007