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

NCT05711017 | Unknown DMC

• 1 other identifier: SCMCIRB- K2022168-2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Community-acquired Pneumonia

Keywords

Pediatric; community-acquired pneumonia; Huashibaidu granule

Outcome Measures

Primary Outcomes (1)

• Change in clinical symptom score from baseline on day 3

  Investigators will compare the change of clinical symptom score from baseline on day 3 in the Huashibaidu group to the placebo group. The main symptoms assessed by the investigators are body temperature (ear temperature), daytime cough, nocturnal cough, productive sputum, thick sputum, wheezing, and shortness of breath; Secondary symptoms include dry stools, decreased appetite, poor spirit, fatigue, and diarrhoea. Each symptom is assigned a score of 0, 1, 2, and 3 by investigators according to the symptoms from mild to severe.

  3 days

Secondary Outcomes (8)

• Anti-infective efficacy of Huashibaidu granule

  5 days

• time to symptom resolution

  5 days

• total effective rate

  5 days

• change on the number of different pathogens sequences

  5 days

• changes in cytokines

  5 days

Study Arms (2)

Huashibaidu

EXPERIMENTAL

During the study, subjects diagnosed as community-acquired pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)" will be assigned to the Huashibaidu group and the placebo group. Then they will receive 5 days treatment, prescribed by investigator according to study design. At the same time, they will finish a series of examinations, including biomarkers associated with infection, screening of pathogen, imaging examination and tNGS.

Drug: Huashibaidu granule

Placebo

PLACEBO COMPARATOR

During the study, subjects diagnosed as community-acquired pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)" will be assigned to the Huashibaidu group and the placebo group. Then they will receive 5 days treatment, prescribed by investigator according to study design. At the same time, they will finish a series of examinations, including biomarkers associated with infection, screening of pathogen, imaging examination and tNGS.

Drug: Placebo

Interventions

Huashibaidu granule DRUG

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).

Also known as: study-specified community-associated pneumonia in children drug program

Huashibaidu

Placebo DRUG

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).

Also known as: study-specified community-associated pneumonia in children drug program

Placebo

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Yong Yin, PhD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Yin, PhD

CONTACT

+8618930830705; yinyong9999@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: February 2, 2023
• Study Start: February 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 2, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share