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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


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 fever

effect 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).


Minimum age: 1 Year. Maximum age: 14 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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