Clinical trial NCT04479657: Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
Official title: A Randomized Controlled Study of Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Upper Respiratory Tract Infection
Bacterial Infection
Chinese Medicine
Pediatric Acute Upper Respiratory Tract Infection
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis with the acute upper respiratory tract infection;
2. Diagnosis with wind-heat Zheng according to Chinese medicine;
3. Age: 5-14 years old;
4. Body temperature ≥ 37.5 ℃;
5. White blood cell count\> 12 × 10\^9 / L, and / or neutrophil ratio over than 70%;
6. The informed consent process complies with the regulations, and the legal agent or the child (≥8 years old) jointly sign the informed consent

Exclusion Criteria:

(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.

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Primary outcomes:
measure: Bacterial clearance
timeFrame: 0, Day 5
Secondary outcomes:
measure: Clinical remission rate of disease
timeFrame: Day 3,Day 5
measure: Fever clearance time
timeFrame: Up to Day 5
measure: Treatment failure rate
timeFrame: Up to Day 5
measure: The incidence of the complications
timeFrame: Up to Day 5
measure: The usage of the ibuprofen
timeFrame: Up to Day 5
measure: The usage of antibiotics (Cefuroxime)
timeFrame: Up to Day 5
measure: The normalization rate of the blood routine
timeFrame: Day 3, Day 5
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongfang Hospital
state: Beijing
Study officials:
References: