NCT05711017

The Effect of Huashibaidu Granule on Community-acquired Pneumonia in Children

The Effect of Huashibaidu Granule on Community-acquired Pneumonia in Children: a Randomized, Double-blind, Placebo-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Children's Medical Center · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the efficacy and safety of Huashibaidu granule for the treatment of community-acquired pneumonia in children compared with placebo and to demonstrate the efficacy of Huashibaidu granule in improving clinical symptoms, removing pathogens, and shortening clinical course.

Detailed description

Subjects diagnosed as community-acquired pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)" at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited. For each enrolled patient, basic information as well as basic medical condition will be collected by investigators. The subjects will be randomly assigned to the Huashibaidu group and the placebo group. During the study, patients will receive Huashibaidu granule or placebo two times a day for five consecutive days. Both groups of patients will receive conventional Western medical observation and symptomatic treatment, including empiric anti-infective therapy (antibiotics) and symptomatic treatment such as antipyretic, expectorant and asthmatic. Do not use other traditional Chinese medicines, proprietary Chinese medicines, and antiviral drugs. Expectorants other than Ambroxol cannot be used. After enrollment, investigator will evaluate and score patients' clinical symptoms at day 0, 1, 2, 3, 4, 5. Detection of biomarkers associated with infection, screening of pathogen and imaging examination will be conducted at day 0. And pharyngeal swab will be collected by investigator for tNGS at day 0, 3, 5.

Conditions

• Community-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Huashibaidu granule	Subjects diagnosed as community-acquired pneumonia in children at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment day, day 0). The subject assigned to the Huashibaidu group will receive Huashibaidu granule two times a day for five consecutive days (day 1\~5).
DRUG	Placebo	Subjects diagnosed as community-acquired pneumonia in children at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment day, day 0). The subject assigned to the placebo group will receive placebo two times a day for five consecutive days (day 1\~5).

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2023-02-02
• Last updated: 2023-02-02