Status:
UNKNOWN
Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
Lead Sponsor:
Zhong Wang
Conditions:
Upper Respiratory Tract Infection
Bacterial Infection
Eligibility:
All Genders
5-14 years
Phase:
EARLY_PHASE1
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- (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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Key Trial Info
Start Date :
October 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04479657
Start Date
October 17 2020
End Date
June 1 2024
Last Update
November 15 2022
Active Locations (1)
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1
Dongfang Hospital
Beijing, Beijing Municipality, China, 100078