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Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

Primary Purpose

Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Xiyanping injection
wind-heat formula granules
phlegm-heat formula granules
Fu-xiong San
second generation cephalosporin
Erythromycin
Azithromycin
Sponsored by
Liaoning University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring pneumonia, pediatrics

Eligibility Criteria

1 Year - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Affiliated Children's Hospital of Capital University of Medical SciencesRecruiting
  • Guangzhou Children's HospitalRecruiting
  • Affiliated hospital of Guangzhou university of Chinese MedicineRecruiting
  • Affiliated Hospital of Guangxi University of Chinese MedicineRecruiting
  • Affiliated Hospital of Changchun University of TCMRecruiting
  • Affiliated Children's Hospital of Dalian Medical UniversityRecruiting
  • Affiliated Hospital of Liaoning University of TCMRecruiting
  • Affiliated Hospital of Shandong University of TCMRecruiting
  • Affiliated Longhua Hospital of Shanghai University of TCMRecruiting
  • First teaching hospital of Tianjin university of TCMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Injection,medications and application

Injection and medications

Injection and application

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

effect in treating fever
temperature, fever frequency,fever lasting time, Ibuprofen Suspension， all to be measured
effect in dyspnea releasing
gasp frequency, severity, all to be measured
effect in phlegm releasing
phlegm amount,color and nature to be measured
effect in cough releasing
cough severity to be measured
time from admission to recovery of rales
TCM syndrome scores
measure is a composite.
effective rate of TCM syndrome scores
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)
days counted when the patient checks out
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
safety (With adverse events as the calculation basis)
With adverse events as the calculation basis

Full Information

First Posted
January 22, 2015
Last Updated
February 12, 2015
Sponsor
Liaoning University of Traditional Chinese Medicine
Collaborators
Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02362906
Brief Title
Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia
Official Title
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
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaoning University of Traditional Chinese Medicine
Collaborators
Beijing University of Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
pneumonia, pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Injection,medications and application
Arm Type
Experimental
Arm Description
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.
Arm Title
Injection and medications
Arm Type
Experimental
Arm Description
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.
Arm Title
Injection and application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Xiyanping injection
Intervention Description
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
Intervention Type
Drug
Intervention Name(s)
wind-heat formula granules
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
phlegm-heat formula granules
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Fu-xiong San
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
second generation cephalosporin
Intervention Type
Drug
Intervention Name(s)
Erythromycin
Intervention Description
ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
Primary Outcome Measure Information:
Title
Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded)
Description
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)
Title
effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear)
Description
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)
Secondary Outcome Measure Information:
Title
effect in treating fever
Description
temperature, fever frequency,fever lasting time, Ibuprofen Suspension， all to be measured
Time Frame
7 days
Title
effect in dyspnea releasing
Description
gasp frequency, severity, all to be measured
Time Frame
7 days
Title
effect in phlegm releasing
Description
phlegm amount,color and nature to be measured
Time Frame
7 days
Title
effect in cough releasing
Description
cough severity to be measured
Time Frame
7 days
Title
time from admission to recovery of rales
Time Frame
7 days
Title
TCM syndrome scores
Description
measure is a composite.
Time Frame
7 days
Title
effective rate of TCM syndrome scores
Description
total effecive rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate
Time Frame
7 days
Title
check-out time (days counted when the patient checks out)
Description
days counted when the patient checks out
Time Frame
7 days
Title
pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up)
Description
prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up
Time Frame
15 days; 30 days; 90 days
Title
safety (With adverse events as the calculation basis)
Description
With adverse events as the calculation basis
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
direct medical cost
Description
medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital
Time Frame
observed during treatment in 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefeng Wang, Ph.D
Phone
13840208807
Facility Information:
Facility Name
Affiliated Children's Hospital of Capital University of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100045
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kunling Shen, Ph. D
Phone
0086-13910727586
First Name & Middle Initial & Last Name & Degree
Kunling Shen, Ph. D
Facility Name
Guangzhou Children's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Deng, Master's
Phone
0086-13711220382
First Name & Middle Initial & Last Name & Degree
Li Deng, Master's
Facility Name
Affiliated hospital of Guangzhou university of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Xu, Ph.D
Phone
13724885258
Facility Name
Affiliated Hospital of Guangxi University of Chinese Medicine
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530023
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lining Wang, Ph.D
Phone
13607717743
Facility Name
Affiliated Hospital of Changchun University of TCM
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130103
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaochun Feng, Ph.D
Phone
13578696998
Facility Name
Affiliated Children's Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenze Cui, Ph. D
Phone
0086-13904084058
First Name & Middle Initial & Last Name & Degree
Zhenze Cui, Ph. D
Facility Name
Affiliated Hospital of Liaoning University of TCM
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefeng Wang, Ph.D.
Phone
0086-13840208807
First Name & Middle Initial & Last Name & Degree
Xuefeng Wang, Ph. D
Facility Name
Affiliated Hospital of Shandong University of TCM
City
Ji'nan
State/Province
Shandong
ZIP/Postal Code
250011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanning Li, Ph. D
Phone
0086-13905313077
First Name & Middle Initial & Last Name & Degree
Yanning Li, Ph. D
Facility Name
Affiliated Longhua Hospital of Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyan Jiang, Bachelor's
Phone
0086-13801868578
First Name & Middle Initial & Last Name & Degree
Zhiyan Jiang, Bachelor's
Facility Name
First teaching hospital of Tianjin university of TCM
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300193
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Ma, Ph.D
Phone
13902095399

12. IPD Sharing Statement

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Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

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