A Randomized Controlled Study of Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bacterial clearance
研究概览
简要总结
The study aims to assess the antibacterial effect and symptoms-relief of Qingfei Granule in the patients with pediatric acute upper respiratory tract infection with bacterial infection.
详细描述
Upper respiratory tract infection is the most common respiratory disease in childhood, and the incidence rate accounts for more than 60% of pediatric outpatients, ranking first in pediatric diseases. At present, antibiotics are commonly used to treat children with upper respiratory tract infections. However, due to the large amount of clinical use of antibiotics in recent years, the resistance of various pathogens has become stronger and stronger, which has caused the majority of clinicians and researchers to turn their attention to traditional Chinese medicine. Qingfei Granule is composed of six common herbal medicines such as Schizonepeta (Jing-Jie),Radix Scutellariae (Huang-qin),Forsythia (Lian-Qiao), etc. After upper respiratory tract infections with bacterial infections, chills, fever, runny nose, red and sore throat may occur, and may be accompanied by mild cough, thin red tongue, yellow moss, floating pulse,which is considered as the exogenous wind-heat Zheng in Chinese medicine. The study aims to assess the antibacterial effect and symptoms-relief of Qingfei Granule in the patients with pediatric acute upper respiratory tract infection with bacterial infection.
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
- None
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with the acute upper respiratory tract infection;
- •Diagnosis with wind-heat Zheng according to Chinese medicine;
- •Age: 5-14 years old;
- •Body temperature ≥ 37.5 ℃;
- •White blood cell count> 12 × 10^9 / L, and / or neutrophil ratio over than 70%;
- •The informed consent process complies with the regulations, and the legal agent or the child (≥8 years old) jointly sign the informed consent
排除标准
- •(1) Acute bacterial otitis media; (2) Patients with periodontitis or periodontal abscess (3) Candidiasis; (4) Patients with positive mycoplasma; (5) Taking antibiotics, anti-inflammatory drugs, and antihistamines; (6) Patients with severe comorbidities of heart, liver and kidney; (7) Other patients with acute infectious diseases and mycoplasma pneumoniae infections with symptoms similar to upper respiratory tract infection; (8) Children with a history of epilepsy or convulsions; (9) Patients with mental illness; (10) Those who are allergic to treatment drugs; (11) Participated in other clinical trials in the past month; (12) The investigator evaluates that it is not suitable to participate in this clinical trial or according to the investigator's judgment, who is likely to loss to follow-up.
研究组 & 干预措施
QingFei Granule+Cefuroxime group
Cefuroxime：30mg/kg/d,bid QingFei Granule: tid
干预措施: QingFei Granule (Drug)
QingFei Granule+Cefuroxime group
Cefuroxime：30mg/kg/d,bid QingFei Granule: tid
干预措施: Cefuroxime (Drug)
Cefuroxime group
Cefuroxime：30mg/kg/d,bid
干预措施: Cefuroxime (Drug)
结局指标
主要结局
Bacterial clearance
时间窗: 0, Day 5
The pharyngeal swabs were used for sampling, and the pharyngeal flora diversity amplicon sequencing was used to analyze the pharyngeal flora spectrum, and the change of pathogenic bacteria flora spectrum before and after treatment was analyzed to qualitatively judge the bacterial clearance. Calculate the bacterial clearance rate = (number of people removed / total number of people tested) × 100%
次要结局
- Fever clearance time(Up to Day 5)
- Clinical remission rate of disease(Day 3,Day 5)
- Treatment failure rate(Up to Day 5)
- The incidence of the complications(Up to Day 5)
- The usage of the ibuprofen(Up to Day 5)
- The usage of antibiotics (Cefuroxime)(Up to Day 5)
- The normalization rate of the blood routine(Day 3, Day 5)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences