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

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhong Wang
• Treatments: Cefuroxime; Cefuroxime axetil

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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