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Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02069665
Recruitment Status : Completed
First Posted : February 24, 2014
Last Update Posted : February 24, 2014
Sponsor:
Collaborator:
Beijing University of Chinese Medicine
Information provided by (Responsible Party):
Xuefeng Wang, Liaoning University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Pneumonia Other: Fuxiong San Drug: Xiyanping injection Drug: Ribavirin Injection Drug: Xiaoer Qingfei Heji (mixture) Drug: Zhi Ke San Drug: Hua Tan San Drug: Guaifenesin Syrup Drug: Ibuprofen Suspension Drug: salbutamol Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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 Name: 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 Name: 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 Name: Guaifenesin, Methylephedrine and Chlorphenamine Syrup

Drug: Ibuprofen Suspension
taken under prescription
Other Name: Motrin

Drug: salbutamol
taken under prescription
Other Name: β2-agonists




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Time of lung rales disappear completely [ Time Frame: 10 days ]
    days are counted since receiving treatment, when the chest radiograph returns to normal

  4. Check-out time [ Time Frame: 10 days ]
    days counted when the patient checks out

  5. Pulmonary disease incidence [ Time Frame: 30 days ]
    unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069665


Locations
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China, Beijing
Affiliated Children's Hospital of Capital University of Medical Sciences
Beijing, Beijing, China, 100045
China, Guangdong
Guangzhou Children's Hospital
Guangzhou, Guangdong, China, 510120
China, Liaoning
Affiliated Children's Hospital of Dalian Medical University
Dalian, Liaoning, China, 116044
Affiliated Hospital of Liaoning University of TCM
Shenyang, Liaoning, China, 110032
China, Shandong
Affiliated Hospital of Shandong University of TCM
Ji'nan, Shandong, China, 250011
China, Shanghai
Affiliated Longhua Hospital of Shanghai University of TCM
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Liaoning University of Traditional Chinese Medicine
Beijing University of Chinese Medicine
Investigators
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Study Director: Xuefeng Wang, Ph.D. Affiliated Hospital of Liaoning University of TCM
Principal Investigator: Zhenqi Wu Affiliated Hospital of Liaoning University of TCM

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Responsible Party: Xuefeng Wang, Chief physician, Liaoning University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02069665    
Other Study ID Numbers: AHLN-TCM-01
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014
Keywords provided by Xuefeng Wang, Liaoning University of Traditional Chinese Medicine:
pneumonia
pediatrics
viral
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ribavirin
Ibuprofen
Phenylpropanolamine
Albuterol
Guaifenesin
Chlorpheniramine, phenylpropanolamine drug combination
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents