The Effect of Huashibaidu Granule on Community-acquired Pneumonia in Children: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in clinical symptom score from baseline on day 3
研究概览
简要总结
The primary purpose of this study is to assess the efficacy and safety of Huashibaidu granule for the treatment of community-acquired pneumonia in children compared with placebo and to demonstrate the efficacy of Huashibaidu granule in improving clinical symptoms, removing pathogens, and shortening clinical course.
详细描述
Subjects diagnosed as community-acquired pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)" at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited. For each enrolled patient, basic information as well as basic medical condition will be collected by investigators. The subjects will be randomly assigned to the Huashibaidu group and the placebo group.
During the study, patients will receive Huashibaidu granule or placebo two times a day for five consecutive days. Both groups of patients will receive conventional Western medical observation and symptomatic treatment, including empiric anti-infective therapy (antibiotics) and symptomatic treatment such as antipyretic, expectorant and asthmatic. Do not use other traditional Chinese medicines, proprietary Chinese medicines, and antiviral drugs. Expectorants other than Ambroxol cannot be used.
After enrollment, investigator will evaluate and score patients' clinical symptoms at day 0, 1, 2, 3, 4, 5. Detection of biomarkers associated with infection, screening of pathogen and imaging examination will be conducted at day 0. And pharyngeal swab will be collected by investigator for tNGS at day 0, 3, 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Han nationality.
- •Diagnosed as community-associated pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)".
- •The first dose was given < 5 days from the onset of pneumonia (onset time is defined as the time of the first symptoms or signs of lower respiratory tract infection).
- •The guardian agrees to participate in the study and signs the informed consent form.
排除标准
- •The subject has severe respiratory distress, cyanosis, consciousness disorder, refusal to eat or dehydration.
- •The subject has chronic respiratory diseases, airway malformations, congenital heart disease, immune system diseases and other serious underlying diseases other than asthma.
- •The subject has moderate to severe persistent asthma or is in the acute asthma exacerbation.
- •The subject with influenza virus, pertussis, tuberculosis, fungi, and parasitic infections.
- •The subject with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 1.5 times higher than normal values in blood biochemical detection items, abnormal renal function, or troponin.
- •The subject with any other reason that investigators consider unsuitable to participate in this study.
研究组 & 干预措施
Huashibaidu
During the study, subjects diagnosed as community-acquired pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)" will be assigned to the Huashibaidu group and the placebo group. Then they will receive 5 days treatment, prescribed by investigator according to study design. At the same time, they will finish a series of examinations, including biomarkers associated with infection, screening of pathogen, imaging examination and tNGS.
干预措施: Huashibaidu granule (Drug)
Placebo
During the study, subjects diagnosed as community-acquired pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)" will be assigned to the Huashibaidu group and the placebo group. Then they will receive 5 days treatment, prescribed by investigator according to study design. At the same time, they will finish a series of examinations, including biomarkers associated with infection, screening of pathogen, imaging examination and tNGS.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in clinical symptom score from baseline on day 3
时间窗: 3 days
Investigators will compare the change of clinical symptom score from baseline on day 3 in the Huashibaidu group to the placebo group. The main symptoms assessed by the investigators are body temperature (ear temperature), daytime cough, nocturnal cough, productive sputum, thick sputum, wheezing, and shortness of breath; Secondary symptoms include dry stools, decreased appetite, poor spirit, fatigue, and diarrhoea. Each symptom is assigned a score of 0, 1, 2, and 3 by investigators according to the symptoms from mild to severe.
次要结局
- Rate of transition to ICU(5 days)
- time to symptom resolution(5 days)
- change on the number of different pathogens sequences(5 days)
- Duration of hospitalization(5 days)
- Anti-infective efficacy of Huashibaidu granule(5 days)
- total effective rate(5 days)
- changes in cytokines(5 days)
- Rate of transition to severe pneumonia(5 days)