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Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fuxiong San
Xiyanping injection
Ribavirin Injection
Xiaoer Qingfei Heji (mixture)
Zhi Ke San
Hua Tan San
Guaifenesin Syrup
Ibuprofen Suspension
salbutamol
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, viral

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Affiliated Children's Hospital of Capital University of Medical Sciences
  • Guangzhou Children's Hospital
  • Affiliated Children's Hospital of Dalian Medical University
  • Affiliated Hospital of Liaoning University of TCM
  • Affiliated Hospital of Shandong University of TCM
  • Affiliated Longhua Hospital of Shanghai University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Injection, medications and application

Injection and medications

Arm Description

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

Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; Ibuprofen Suspension, and salbutamol in case of different symptoms

Outcomes

Primary Outcome Measures

Cured rate
Clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded.
Effectiveness time window
days range from treatment is received to the effectiveness is observed, and symptoms disappear

Secondary Outcome Measures

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

Full Information

First Posted
December 26, 2013
Last Updated
February 20, 2014
Sponsor
Liaoning University of Traditional Chinese Medicine
Collaborators
Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02069665
Brief Title
Effectiveness Study of Integrative Treatment for Pediatric Pneumonia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

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 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).

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Injection, medications and application
Arm Type
Experimental
Arm Description
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
Arm Title
Injection and medications
Arm Type
Active Comparator
Arm Description
Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; Ibuprofen Suspension, and salbutamol in case of different symptoms
Intervention Type
Other
Intervention Name(s)
Fuxiong San
Intervention Description
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
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)
Ribavirin Injection
Intervention Description
ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
Intervention Type
Drug
Intervention Name(s)
Xiaoer Qingfei Heji (mixture)
Intervention Description
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;
Intervention Type
Drug
Intervention Name(s)
Zhi Ke San
Other Intervention Name(s)
herbal powder to relieve cough
Intervention Description
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;
Intervention Type
Drug
Intervention Name(s)
Hua Tan San
Other Intervention Name(s)
herbal powder to remove phlegm
Intervention Description
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;
Intervention Type
Drug
Intervention Name(s)
Guaifenesin Syrup
Other Intervention Name(s)
Guaifenesin, Methylephedrine and Chlorphenamine Syrup
Intervention Description
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;
Intervention Type
Drug
Intervention Name(s)
Ibuprofen Suspension
Other Intervention Name(s)
Motrin
Intervention Description
taken under prescription
Intervention Type
Drug
Intervention Name(s)
salbutamol
Other Intervention Name(s)
β2-agonists
Intervention Description
taken under prescription
Primary Outcome Measure Information:
Title
Cured rate
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 10 days (times)
Title
Effectiveness time window
Description
days range from treatment is received to the effectiveness is observed, and symptoms disappear
Time Frame
Every day since receiving treatment, all together 10 days (times)
Secondary Outcome Measure Information:
Title
TCM syndrome scores and effective rate
Description
Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate
Time Frame
10 days
Title
Effect in fever, cough, phlegm and gasp
Description
temperature, fever frequency, fever lasting time, Ibuprofen Suspension dosing; cough severity; phlegm amount, color and nature; gasp frequency, severity, all to be measured
Time Frame
10 days
Title
Time of lung rales disappear completely
Description
days are counted since receiving treatment, when the chest radiograph returns to normal
Time Frame
10 days
Title
Check-out time
Description
days counted when the patient checks out
Time Frame
10 days
Title
Pulmonary disease incidence
Description
unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Direct medical cost
Description
Medical cost including hospital expenses, examine fee, medication fee, et al, related to treatment in hospital
Time Frame
observed during treatment in 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuefeng Wang, Ph.D.
Organizational Affiliation
Affiliated Hospital of Liaoning University of TCM
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhenqi Wu
Organizational Affiliation
Affiliated Hospital of Liaoning University of TCM
Official's Role
Principal Investigator
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
Facility Name
Guangzhou Children's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Affiliated Children's Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116044
Country
China
Facility Name
Affiliated Hospital of Liaoning University of TCM
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110032
Country
China
Facility Name
Affiliated Hospital of Shandong University of TCM
City
Ji'nan
State/Province
Shandong
ZIP/Postal Code
250011
Country
China
Facility Name
Affiliated Longhua Hospital of Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

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