Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection

Last updated: November 14, 2022
Sponsor: Zhong Wang
Overall Status: Active - Recruiting

Phase

1

Condition

Bacterial Infections

Respiratory Syncytial Virus (Rsv) Infection

Bronchitis (Pediatric)

Treatment

N/A

Clinical Study ID

NCT04479657
QFKL V3.0
  • Ages 5-14
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thechild (≥8 years old) jointly sign the informed consent

Exclusion

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 ofheart, liver and kidney; (7) Other patients with acute infectious diseases and mycoplasmapneumoniae 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 inthe past month; (12) The investigator evaluates that it is not suitable to participate inthis clinical trial or according to the investigator's judgment, who is likely to loss tofollow-up.

Study Design

Total Participants: 60
Study Start date:
October 17, 2020
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Dongfang Hospital

    Beijing, Beijing 100078
    China

    Active - Recruiting

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