Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by PRC National Clinical Research Base of Traditional Chinese Medicine for Major Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Fuxiong San
- Conditions
- Pneumonia
- Sponsor
- Liaoning University of Traditional Chinese Medicine
- Enrollment
- 451
- Locations
- 6
- Primary Endpoint
- Cured rate
- Status
- Completed
- Last Updated
- 12 years ago
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 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).
Investigators
Xuefeng Wang
Chief physician
Liaoning University of Traditional Chinese Medicine
Eligibility Criteria
Inclusion Criteria
- •children, aged 6 months to 59 months old, diagnosed as pneumonia according to western medicine diagnostic criteria;
- •diagnosed as TCM pneumonia with gasp-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
- •emergency pneumonia;
- •complicated with other Pulmonary Disorders attack other than pneumonia;
- •complicated with primary disease of heart (congenital heart disease, myocarditis, et al), liver (ALT, and AST ≥ 1.5 times of normal value ceiling), kidney (BUN \> 8.2mmol/L, or serum CR \> 104 µmol/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.
Arms & Interventions
Injection, medications and application
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
Intervention: Fuxiong San
Injection, medications and application
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
Intervention: Xiyanping injection
Injection, medications and application
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
Intervention: Xiaoer Qingfei Heji (mixture)
Injection, medications and application
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
Intervention: Zhi Ke San
Injection, medications and application
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
Intervention: Hua Tan San
Injection and medications
Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms
Intervention: Ribavirin Injection
Injection and medications
Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms
Intervention: Guaifenesin Syrup
Injection and medications
Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms
Intervention: Ibuprofen Suspension
Injection and medications
Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms
Intervention: salbutamol
Outcomes
Primary Outcomes
Cured rate
Time Frame: Every day since receiving treatment, all together 10 days (times)
Clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded.
Effectiveness time window
Time Frame: Every day since receiving treatment, all together 10 days (times)
days range from treatment is received to the effectiveness is observed, and symptoms disappear
Secondary Outcomes
- TCM syndrome scores and effective rate(10 days)
- Effect in fever, cough, phlegm and gasp(10 days)
- Time of lung rales disappear completely(10 days)
- Check-out time(10 days)
- Pulmonary disease incidence(30 days)