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Trial record 82 of 182 for:    ERYTHROMYCIN

Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT02362906
Recruitment Status : Unknown
Verified February 2015 by Xuefeng Wang, Liaoning University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : February 13, 2015
Last Update Posted : February 13, 2015
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 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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 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 the Special Scientific Research Fund of Public Welfare Profession of China
Study Start Date : April 2014
Estimated Primary Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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




Primary Outcome Measures :
  1. Cured rate (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) ]
    clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded

  2. effective time window (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) ]
    days range from treatment is received to the effectiveness is observed, and symptoms disappear


Secondary Outcome Measures :
  1. effect in treating fever [ Time Frame: 7 days ]
    temperature, fever frequency,fever lasting time, Ibuprofen Suspension, all to be measured

  2. effect in dyspnea releasing [ Time Frame: 7 days ]
    gasp frequency, severity, all to be measured

  3. effect in phlegm releasing [ Time Frame: 7 days ]
    phlegm amount,color and nature to be measured

  4. effect in cough releasing [ Time Frame: 7 days ]
    cough severity to be measured

  5. time from admission to recovery of rales [ Time Frame: 7 days ]
  6. TCM syndrome scores [ Time Frame: 7 days ]
    measure is a composite.

  7. effective rate of TCM syndrome scores [ Time Frame: 7 days ]
    total effecive rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate

  8. check-out time (days counted when the patient checks out) [ Time Frame: 7 days ]
    days counted when the patient checks out

  9. pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up) [ Time Frame: 15 days; 30 days; 90 days ]
    prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up

  10. safety (With adverse events as the calculation basis) [ Time Frame: 7 days ]
    With adverse events as the calculation basis


Other Outcome Measures:
  1. direct medical cost [ Time Frame: observed during treatment in 7 days ]
    medical cost including hospital expenses, examine fee, medication fee, et al, relate 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:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT02362906


Contacts
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Contact: Xuefeng Wang, Ph.D 13840208807

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

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Responsible Party: Xuefeng Wang, Chief physician, Liaoning University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02362906     History of Changes
Other Study ID Numbers: 201307007
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015
Keywords provided by Xuefeng Wang, Liaoning University of Traditional Chinese Medicine:
pneumonia
pediatrics
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action