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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,500
- Locations
- 10
- Primary Endpoint
- Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded)
Study Overview
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.
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Xiyanping injection (Drug)
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.
Intervention: wind-heat formula granules (Drug)
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.
Intervention: phlegm-heat formula granules (Drug)
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.
Intervention: Fu-xiong San (Drug)
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.
Intervention: second generation cephalosporin (Drug)
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.
Intervention: Erythromycin (Drug)
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.
Intervention: Azithromycin (Drug)
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.
Intervention: Xiyanping injection (Drug)
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.
Intervention: wind-heat formula granules (Drug)
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.
Intervention: phlegm-heat formula granules (Drug)
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.
Intervention: second generation cephalosporin (Drug)
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.
Intervention: Erythromycin (Drug)
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.
Intervention: Azithromycin (Drug)
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.
Intervention: Xiyanping injection (Drug)
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.
Intervention: Fu-xiong San (Drug)
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.
Intervention: second generation cephalosporin (Drug)
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.
Intervention: Erythromycin (Drug)
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.
Intervention: Azithromycin (Drug)
Outcomes
Primary Outcomes
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
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 Outcomes
- effect in treating fever(7 days)
- effect in dyspnea releasing(7 days)
- TCM syndrome scores(7 days)
- effect in phlegm releasing(7 days)
- effect in cough releasing(7 days)
- time from admission to recovery of rales(7 days)
- effective rate of TCM syndrome scores(7 days)
- check-out time (days counted when the patient checks out)(7 days)
- pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up)(15 days; 30 days; 90 days)
- safety (With adverse events as the calculation basis)(7 days)
Investigators
Xuefeng Wang
Chief physician
Liaoning University of Traditional Chinese Medicine