Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05711017
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-02
First Post:
2022-12-20
Brief Title:
The Effect of Huashibaidu Granule on Community-acquired Pneumonia in Children
Sponsor:
Shanghai Childrens Medical Center
Organization:
Shanghai Childrens Medical Center
Study Overview
Official Title:
The Effect of Huashibaidu Granule on Community-acquired Pneumonia in Children a Randomized Double-blind Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Childrens 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None