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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 451
- 试验地点
- 6
- 主要终点
- Cured rate
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Fuxiong San (Other)
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
干预措施: Xiyanping injection (Drug)
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
干预措施: Xiaoer Qingfei Heji (mixture) (Drug)
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
干预措施: Zhi Ke San (Drug)
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
干预措施: Hua Tan San (Drug)
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
干预措施: Ribavirin Injection (Drug)
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
干预措施: Guaifenesin Syrup (Drug)
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
干预措施: Ibuprofen Suspension (Drug)
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
干预措施: salbutamol (Drug)
结局指标
主要结局
Cured rate
时间窗: 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
时间窗: Every day since receiving treatment, all together 10 days (times)
days range from treatment is received to the effectiveness is observed, and symptoms disappear
次要结局
- 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)
研究者
Xuefeng Wang
Chief physician
Liaoning University of Traditional Chinese Medicine