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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
QingFei Granule is made from 6 commonly herbal medicine granule, such as Jingjie,Huang Qin,Lianqiao,etc. The children were given one package of QingFei Granule every day, dividing into 3 times to be administrated. It's be given for 5 days.
30mg/kg/d,bid, used until to the normalization of blood routine。
Dongfang Hospital
Beijing, Beijing Municipality, China
RECRUITINGBacterial clearance
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%
Time frame: 0, Day 5
Clinical remission rate of disease
The clinical remission rate of disease is defined as: the main symptoms such as chills, fever, nasal congestion, runny nose, sore throat, cough, etc. alleviate or disappear. Upper respiratory tract infection symptom scale score decreased by more than 70% compared with baseline
Time frame: Day 3,Day 5
Fever clearance time
record once every 4 to 8 h after treatment.
Time frame: Up to Day 5
Treatment failure rate
Treatment failure is defined as: body temperature does not decrease for 3 consecutive days, and / or complicated by laryngitis, tracheobronchitis, pneumonia, myocarditis, and / or oral antibiotics are switched to intravenous antibiotics.
Time frame: Up to Day 5
The incidence of the complications
complicated with laryngitis, tracheo-bronchitis, pneumonia, myocarditis and other complications
Time frame: Up to Day 5
The usage of the ibuprofen
If the temperature is over 38.5℃ or the child feel unbearable discomfort, the child will be given with ibuprofen. The usage of the ibuprofen (including the usage times and detail amount will be recorded in the patients' dairy.
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Time frame: Up to Day 5
The usage of antibiotics (Cefuroxime)
The usage of Cefuroxime (including the usage times and detail amount will be recorded in the patients' dairy.
Time frame: Up to Day 5
The normalization rate of the blood routine
Time frame: Day 3, Day 5