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| Name | Class |
|---|---|
| Beijing University of Chinese Medicine | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection,medications and application | Experimental | 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. |
|
| Injection and medications | Experimental | 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. |
|
| Injection and application | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiyanping injection | Drug | ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded) | clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded | every day since receiving treatment,all together 7 days (times) |
| effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear) | days range from treatment is received to the effectiveness is observed, and symptoms disappear | every day since receiving treatment, all together 7 days (times) |
| Measure | Description | Time Frame |
|---|---|---|
| effect in treating fever | temperature, fever frequency,fever lasting time, Ibuprofen Suspension， all to be measured | 7 days |
| effect in dyspnea releasing | gasp frequency, severity, all to be measured |
| Measure | Description | Time Frame |
|---|---|---|
| direct medical cost | medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital | observed during treatment in 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuefeng Wang, Ph.D | Contact | 13840208807 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Children's Hospital of Capital University of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100045 | China |
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| wind-heat formula granules | Drug | 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 |
|
| phlegm-heat formula granules | Drug | 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 |
|
| Fu-xiong San | Drug | 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 |
|
| second generation cephalosporin | Drug |
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| Erythromycin | Drug | ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection |
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| Azithromycin | Drug | ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection |
|
| 7 days |
| effect in phlegm releasing | phlegm amount,color and nature to be measured | 7 days |
| effect in cough releasing | cough severity to be measured | 7 days |
| time from admission to recovery of rales | 7 days |
| TCM syndrome scores | measure is a composite. | 7 days |
| effective rate of TCM syndrome scores | total effecive rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate | 7 days |
| check-out time (days counted when the patient checks out) | days counted when the patient checks out | 7 days |
| pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up) | 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) | With adverse events as the calculation basis | 7 days |
| Guangzhou Children's Hospital | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Affiliated hospital of Guangzhou university of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510405 | China |
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| Affiliated Hospital of Guangxi University of Chinese Medicine | Recruiting | Nanning | Guangxi | 530023 | China |
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| Affiliated Hospital of Changchun University of TCM | Recruiting | Changchun | Jilin | 130103 | China |
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| Affiliated Children's Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116044 | China |
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| Affiliated Hospital of Liaoning University of TCM | Recruiting | Shenyang | Liaoning | 110032 | China |
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| Affiliated Hospital of Shandong University of TCM | Recruiting | Ji'nan | Shandong | 250011 | China |
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| Affiliated Longhua Hospital of Shanghai University of TCM | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| First teaching hospital of Tianjin university of TCM | Recruiting | Tianjin | Tianjin Municipality | 300193 | China |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000097909 | Second Generation Cephalosporins |
| D004917 | Erythromycin |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D000097902 | beta Lactam Antibiotics |
| D000900 | Anti-Bacterial Agents |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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