Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

February 20, 2014 updated by: Xuefeng Wang, Liaoning University of Traditional Chinese Medicine

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

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

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

451

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100045
        • Affiliated Children's Hospital of Capital University of Medical Sciences
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangzhou Children's Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116044
        • Affiliated Children's Hospital of Dalian Medical University
      • Shenyang, Liaoning, China, 110032
        • Affiliated Hospital of Liaoning University of TCM
    • Shandong
      • Ji'nan, Shandong, China, 250011
        • Affiliated Hospital of Shandong University of TCM
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Affiliated Longhua Hospital of Shanghai University of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injection, medications and application

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
Other: Fuxiong San
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
Drug: Xiyanping injection
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
Drug: Xiaoer Qingfei Heji (mixture)
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;
Drug: Zhi Ke San
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;
Other Names:
  • herbal powder to relieve cough
Drug: Hua Tan San
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;
Other Names:
  • herbal powder to remove phlegm
Active Comparator: Injection and medications

Intravenous injection: Ribavirin Injection;

Medications: symptomatic therapies

  • Guaifenesin Syrup, for removing phlegm, relieving gasp-cough;
  • Ibuprofen Suspension, and salbutamol in case of different symptoms
Drug: Ribavirin Injection
ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
Drug: Guaifenesin Syrup
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;
Other Names:
  • Guaifenesin, Methylephedrine and Chlorphenamine Syrup
Drug: Ibuprofen Suspension
taken under prescription
Other Names:
  • Motrin
Drug: salbutamol
taken under prescription
Other Names:
  • β2-agonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cured rate
Time Frame: Every day since receiving treatment, all together 10 days (times)
Clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded.
Every day since receiving treatment, all together 10 days (times)
Effectiveness time window
Time Frame: Every day since receiving treatment, all together 10 days (times)
days range from treatment is received to the effectiveness is observed, and symptoms disappear
Every day since receiving treatment, all together 10 days (times)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TCM syndrome scores and effective rate
Time Frame: 10 days
Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate
10 days
Effect in fever, cough, phlegm and gasp
Time Frame: 10 days
temperature, fever frequency, fever lasting time, Ibuprofen Suspension dosing; cough severity; phlegm amount, color and nature; gasp frequency, severity, all to be measured
10 days
Time of lung rales disappear completely
Time Frame: 10 days
days are counted since receiving treatment, when the chest radiograph returns to normal
10 days
Check-out time
Time Frame: 10 days
days counted when the patient checks out
10 days
Pulmonary disease incidence
Time Frame: 30 days
unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct medical cost
Time Frame: observed during treatment in 10 days
Medical cost including hospital expenses, examine fee, medication fee, et al, related to treatment in hospital
observed during treatment in 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaoning University of Traditional Chinese Medicine

Collaborators

Beijing University of Chinese Medicine

Investigators

  • Study Director: Xuefeng Wang, Ph.D., Affiliated Hospital of Liaoning University of TCM
  • Principal Investigator: Zhenqi Wu, Affiliated Hospital of Liaoning University of TCM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 26, 2013

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHLN-TCM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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