An interventional study of Fuxiong San and Xiyanping injection in Pneumonia, sponsored by Liaoning University of Traditional Chinese Medicine. Completed at 6 sites in China. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2014-02-24.
Sponsored by Liaoning University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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).
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 451 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Liaoning University of Traditional Chinese Medicine is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous injection: 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): Xiaoer Qingfei Heji (mixture), and Zhi Ke San (herbal powder to relieve cough) * Phlegm-heat blocking lungs pattern (tan re bi fei zheng): Xiaoer Qingfei Heji (mixture), and Hua Tan San (herbal powder to remove phlegm) External application: Fuxiong San
Other: Fuxiong San · Drug: Xiyanping injection · Drug: Xiaoer Qingfei Heji (mixture) · Drug: Zhi Ke San · Drug: Hua Tan San
Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms
Drug: Ribavirin Injection · Drug: Guaifenesin Syrup · Drug: Ibuprofen Suspension · Drug: salbutamol
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
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
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;
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;
Also known as: herbal powder to relieve cough
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;
Also known as: herbal powder to remove phlegm
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;
Also known as: Guaifenesin, Methylephedrine and Chlorphenamine Syrup
taken under prescription
Also known as: Motrin
taken under prescription
Also known as: β2-agonists
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 10 days (times)
Effectiveness 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 10 days (times)
TCM syndrome scores and effective rate
Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate
Time frame: 10 days
Effect in fever, cough, phlegm and gasp
temperature, fever frequency, fever lasting time, Ibuprofen Suspension dosing; cough severity; phlegm amount, color and nature; gasp frequency, severity, all to be measured
Time frame: 10 days
Time of lung rales disappear completely
days are counted since receiving treatment, when the chest radiograph returns to normal
Time frame: 10 days
Check-out time
days counted when the patient checks out
Time frame: 10 days
Pulmonary disease incidence
unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up
Time frame: 30 days
Direct medical cost
Medical cost including hospital expenses, examine fee, medication fee, et al, related to treatment in hospital
Time frame: observed during treatment in 10 days
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Liaoning University of Traditional Chinese Medicine