Effectiveness Study of Integrative Treatment for Pediatric Pneumonia
- Conditions
- Pneumonia
- Interventions
- Other: Fuxiong SanDrug: Zhi Ke SanDrug: Hua Tan San
- Registration Number
- NCT02069665
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 451
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Injection and medications Ibuprofen Suspension Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms Injection, medications and application Fuxiong San 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 Injection, medications and application Zhi Ke San 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 Injection, medications and application Hua Tan San 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 Injection and medications Ribavirin Injection Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms Injection and medications Guaifenesin Syrup Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms Injection and medications salbutamol Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms Injection, medications and application Xiyanping injection 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 Injection, medications and application Xiaoer Qingfei Heji (mixture) 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
- Primary Outcome Measures
Name Time Method Cured rate 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 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 Outcome Measures
Name Time Method TCM syndrome scores and effective rate 10 days Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate
Effect in fever, cough, phlegm and gasp 10 days temperature, fever frequency, fever lasting time, Ibuprofen Suspension dosing; cough severity; phlegm amount, color and nature; gasp frequency, severity, all to be measured
Time of lung rales disappear completely 10 days days are counted since receiving treatment, when the chest radiograph returns to normal
Check-out time 10 days days counted when the patient checks out
Pulmonary disease incidence 30 days unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up
Trial Locations
- Locations (6)
Affiliated Children's Hospital of Capital University of Medical Sciences
🇨🇳Beijing, Beijing, China
Affiliated Children's Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Affiliated Hospital of Liaoning University of TCM
🇨🇳Shenyang, Liaoning, China
Guangzhou Children's Hospital
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Shandong University of TCM
🇨🇳Ji'nan, Shandong, China
Affiliated Longhua Hospital of Shanghai University of TCM
🇨🇳Shanghai, Shanghai, China