UnknownNot Applicable

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

100 participantsStarted 2023-02-01

Plain-language 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.

Who can participate

Age range3 Years – 6 Years

SexALL

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Inclusion criteria

✓. Han nationality.
✓. Diagnosed as community-associated pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)".
✓. The first dose was given \< 5 days from the onset of pneumonia (onset time is defined as the time of the first symptoms or signs of lower respiratory tract infection).
✓. The guardian agrees to participate in the study and signs the informed consent form.

Exclusion criteria

✕. The subject has severe respiratory distress, cyanosis, consciousness disorder, refusal to eat or dehydration.
✕. The subject has chronic respiratory diseases, airway malformations, congenital heart disease, immune system diseases and other serious underlying diseases other than asthma.
✕. The subject has moderate to severe persistent asthma or is in the acute asthma exacerbation.
✕. The subject with influenza virus, pertussis, tuberculosis, fungi, and parasitic infections.
✕. The subject with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 1.5 times higher than normal values in blood biochemical detection items, abnormal renal function, or troponin.
✕. The subject with any other reason that investigators consider unsuitable to participate in this study.

What they're measuring

Change in clinical symptom score from baseline on day 3

Timeframe: 3 days

Trial details

NCT IDNCT05711017

SponsorShanghai Children's Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-31

Contact for this trial

Yong Yin, PhD

+8618930830705 yinyong9999@163.com

View on ClinicalTrials.gov More Community-acquired Pneumonia trials