Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia
Information source: Liaoning University of Traditional Chinese Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia
Intervention: Xiyanping injection (Drug); wind-heat formula granules (Drug); phlegm-heat formula granules (Drug); Fu-xiong San (Drug); second generation cephalosporin (Drug); Erythromycin (Drug); Azithromycin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Liaoning University of Traditional Chinese Medicine Overall contact: Xuefeng Wang, Ph.D, Phone: 13840208807
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cured rate (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)
Secondary outcome: effect in treating fevereffect in dyspnea releasing effect in phlegm releasing effect in cough releasing time from admission to recovery of rales TCM syndrome scores effective rate of TCM syndrome scores check-out time (days counted when the patient checks out) pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up) safety (With adverse events as the calculation basis)
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).
Eligibility
Minimum age: 1 Year.
Maximum age: 14 Years.
Gender(s): Both.
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.
Locations and Contacts
Xuefeng Wang, Ph.D, Phone: 13840208807
Affiliated Children's Hospital of Capital University of Medical Sciences, Beijing, Beijing 100045, China; Recruiting Kunling Shen, Ph. D, Phone: 0086-13910727586 Kunling Shen, Ph. D, Principal Investigator
Affiliated hospital of Guangzhou university of Chinese Medicine, Guangzhou, Guangdong 510405, China; Recruiting Hua Xu, Ph.D, Phone: 13724885258
Guangzhou Children's Hospital, Guangzhou, Guangdong 510120, China; Recruiting Li Deng, Master's, Phone: 0086-13711220382 Li Deng, Master's, Principal Investigator
Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, Guangxi 530023, China; Recruiting Lining Wang, Ph.D, Phone: 13607717743
Affiliated Hospital of Changchun University of TCM, Changchun, Jilin 130103, China; Recruiting Xiaochun Feng, Ph.D, Phone: 13578696998
Affiliated Children's Hospital of Dalian Medical University, Dalian, Liaoning 116044, China; Recruiting Zhenze Cui, Ph. D, Phone: 0086-13904084058 Zhenze Cui, Ph. D, Principal Investigator
Affiliated Hospital of Liaoning University of TCM, Shenyang, Liaoning 110032, China; Recruiting Xuefeng Wang, Ph.D., Phone: 0086-13840208807 Xuefeng Wang, Ph. D, Principal Investigator
Affiliated Hospital of Shandong University of TCM, Ji'nan, Shandong 250011, China; Recruiting Yanning Li, Ph. D, Phone: 0086-13905313077 Yanning Li, Ph. D, Principal Investigator
Affiliated Longhua Hospital of Shanghai University of TCM, Shanghai, Shanghai 200032, China; Recruiting Zhiyan Jiang, Bachelor's, Phone: 0086-13801868578 Zhiyan Jiang, Bachelor's, Principal Investigator
First teaching hospital of Tianjin university of TCM, Tianjin, Tianjin 300193, China; Recruiting Rong Ma, Ph.D, Phone: 13902095399
Additional Information
Starting date: April 2014
Last updated: February 12, 2015
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