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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 retrospective case study has been finished at the National clinical research base of traditional Chinese medicine for major disease pediatric pneumonia, and the research center organized the field training of prospective-study to coordinated units. Based on the primary statistical outcomes of retrospective case study and the discussion around prospective-study during the training, investigators found it difficult to include simplex viral infection, therefore, investigators revised the inclusion criteria and treatment protocol of the pragmatic randomized controlled trial.
The block randomization is used in this trial. Random numbers are generated by SPSS software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 369, and considering drop-out or withdrawal, investigators plan to enroll 450 patients (300 in experimental group, 150 in control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection, medications and application | Experimental | Intravenous injection: Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co., Ltd; Medications: according to TCM syndrome differentiations;
External application: Fuxiong San |
|
| Injection and medications | Active Comparator | Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fuxiong San | Other | external application; 8-10cm wide, 0.3-0.5cm thick; 10mins for patient aged 1 to 3-year old; 15mins for those aged 3 to 5-year old; once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cured rate | Clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded. | Every day since receiving treatment, all together 10 days (times) |
| Effectiveness time window | days range from treatment is received to the effectiveness is observed, and symptoms disappear | Every day since receiving treatment, all together 10 days (times) |
| Measure | Description | Time Frame |
|---|---|---|
| TCM syndrome scores and effective rate | Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate | 10 days |
| Effect in fever, cough, phlegm and gasp |
| Measure | Description | Time Frame |
|---|---|---|
| Direct medical cost | Medical cost including hospital expenses, examine fee, medication fee, et al, related to treatment in hospital | observed during treatment in 10 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuefeng Wang, Ph.D. | Affiliated Hospital of Liaoning University of TCM | Study Director |
| Zhenqi Wu | Affiliated Hospital of Liaoning University of TCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Children's Hospital of Capital University of Medical Sciences | Beijing | Beijing Municipality | 100045 | China | ||
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| Xiyanping injection | Drug | ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection. |
|
| Ribavirin Injection | Drug | ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection. |
|
| Xiaoer Qingfei Heji (mixture) | Drug | children aged 6 months to 1 year old: 10 ml, orally taken three times daily; children aged 1 to 3 year old: 15 ml, orally taken three times daily; children aged 3 to 5 year old: 20 ml, orally taken three times daily; |
|
| Zhi Ke San | Drug | children aged 6 months to 1 year old: 0.5g, orally taken three times daily; children aged 1 to 3 year old: 1.5g, orally taken three times daily; children aged 3 to 5 year old: 2.0g, orally taken three times daily; |
|
|
| Hua Tan San | Drug | children aged 6 months to 1 year old: 0.5g, orally taken three times daily; children aged 1 to 3 year old: 1.5g, orally taken three times daily; children aged 3 to 5 year old: 2.0g, orally taken three times daily; |
|
|
| Guaifenesin Syrup | Drug | children aged 6 months to 1 year old: 3ml, orally taken three times daily; children aged 1 to 3 year old: 5ml, orally taken three times daily; children aged 3 to 5 year old: 8ml, orally taken three times daily; |
|
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| Ibuprofen Suspension | Drug | taken under prescription |
|
|
| salbutamol | Drug | taken under prescription |
|
|
temperature, fever frequency, fever lasting time, Ibuprofen Suspension dosing; cough severity; phlegm amount, color and nature; gasp frequency, severity, all to be measured
| 10 days |
| Time of lung rales disappear completely | days are counted since receiving treatment, when the chest radiograph returns to normal | 10 days |
| Check-out time | days counted when the patient checks out | 10 days |
| Pulmonary disease incidence | unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up | 30 days |
| Guangzhou Children's Hospital |
| Guangzhou |
| Guangdong |
| 510120 |
| China |
| Affiliated Children's Hospital of Dalian Medical University | Dalian | Liaoning | 116044 | China |
| Affiliated Hospital of Liaoning University of TCM | Shenyang | Liaoning | 110032 | China |
| Affiliated Hospital of Shandong University of TCM | Ji'nan | Shandong | 250011 | China |
| Affiliated Longhua Hospital of Shanghai University of TCM | Shanghai | Shanghai Municipality | 200032 | China |
| 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 |
|---|---|
| D012254 | Ribavirin |
| D006140 | Guaifenesin |
| C041707 | N-methylephedrine |
| D007052 | Ibuprofen |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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