Back to resultsEfficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children
Primary Purpose
Acute Bronchitis in Children
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Xiyanping injection
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bronchitis in Children
Eligibility Criteria
Inclusion Criteria:
- Age: 1-6 years (>1 years, ≤6years);
- Children who meet the diagnosis criteria of acute bronchitis in children;
- All symptoms, including cough, had been present for less than 72 hours at the time of inclusion screening;
- The informed consent process complies with the regulations, and the legal guardian signs the informed consent.
Exclusion Criteria:
- Have used Chinese medicine injection containing andrographolide and similar functions (clearing heat and detoxifying, relieving cough and stopping dysentery) or oral dosage within 72 hours.
- Children with severe bronchitis or early pneumonia;
- Children with acute infectious diseases such as measles, pertussis,influenza and hand-foot-and-mouth disease;
- Children with diseases such as acute upper respiratory tract infection, suppurative tonsillitis, wheezing bronchitis, bronchial asthma, bronchiolitis pneumonia, tuberculosis, tumor;
- neutrophil granulocyte>80%, or those who need antibiotic therapy;
- Children with severe malnutrition and immunodeficiency;
- Children with severe primary diseases such as heart, liver, kidney, digestion and hematopoietic system;
- Allergic constitution and children allergic to the drug used in this study;
- Children who are taking epinephrine, isoproterenol and other catecholamines;
- Children who are taking MAO inhibitors or tricyclic antidepressants
- Children who are taking non-selective β-blockers such as Propranolol;
- Those who are not included based on the investigators judgment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Xiyanping injection combined with routine treatment
routine treatment
Arm Description
Outcomes
Primary Outcome Measures
Total clinical effective rate
The children were evaluated according to the improvement of body temperature (axillary temperature), cough, expectoration, lung rales and other symptoms and signs and the improvement time
Secondary Outcome Measures
Cough easing
Symptoms are less than or equal to 1 point (mild) and remain for 24 hours or more
Lung rales relieved
Symptoms are less than or equal to 1 point (mild) and remain for 24 hours or more
Fever relief
Body temperature <37.5℃ (axillary temperature) and maintained for 24h or more
Full Information
NCT ID
NCT04926506
First Posted
June 9, 2021
Last Updated
September 27, 2021
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04926506
Brief Title
Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children
Official Title
Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children: a Multicenter, Randomized, Parallel Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2021 (Anticipated)
Primary Completion Date
September 21, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Any pathogen that causes an upper respiratory tract infection can cause bronchitis.The primary pathogen is virus. On the basis of virus infection, pathogenic bacteria may cause secondary infection or co-infection。Xiyanping injection is mainly used in the treatment of bronchitis by intravenous injection。
Detailed Description
To further verify the clinical value and safety of intramuscular injection of Xiyanping injection in the treatment of acute bronchitis in children, provide reference for subsequent validation studies, and provide more reasonable and standard application guidance and basis for clinical practice.A multicenter, randomized, parallel controlled study was conducted on the treatment of acute bronchitis by intramuscular injection of Xiyanping injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xiyanping injection combined with routine treatment
Arm Type
Experimental
Arm Title
routine treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Xiyanping injection
Intervention Description
Intramuscular injection of Xiyanping injection, 0.3mL / (kg.d) daily, Bid
Primary Outcome Measure Information:
Title
Total clinical effective rate
Description
The children were evaluated according to the improvement of body temperature (axillary temperature), cough, expectoration, lung rales and other symptoms and signs and the improvement time
Time Frame
up to day 7
Secondary Outcome Measure Information:
Title
Cough easing
Description
Symptoms are less than or equal to 1 point (mild) and remain for 24 hours or more
Time Frame
up to day 7
Title
Lung rales relieved
Description
Symptoms are less than or equal to 1 point (mild) and remain for 24 hours or more
Time Frame
up to day 7
Title
Fever relief
Description
Body temperature <37.5℃ (axillary temperature) and maintained for 24h or more
Time Frame
up to day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 1-6 years (>1 years, ≤6years);
Children who meet the diagnosis criteria of acute bronchitis in children;
All symptoms, including cough, had been present for less than 72 hours at the time of inclusion screening;
The informed consent process complies with the regulations, and the legal guardian signs the informed consent.
Exclusion Criteria:
Have used Chinese medicine injection containing andrographolide and similar functions (clearing heat and detoxifying, relieving cough and stopping dysentery) or oral dosage within 72 hours.
Children with severe bronchitis or early pneumonia;
Children with acute infectious diseases such as measles, pertussis,influenza and hand-foot-and-mouth disease;
Children with diseases such as acute upper respiratory tract infection, suppurative tonsillitis, wheezing bronchitis, bronchial asthma, bronchiolitis pneumonia, tuberculosis, tumor;
neutrophil granulocyte>80%, or those who need antibiotic therapy;
Children with severe malnutrition and immunodeficiency;
Children with severe primary diseases such as heart, liver, kidney, digestion and hematopoietic system;
Allergic constitution and children allergic to the drug used in this study;
Children who are taking epinephrine, isoproterenol and other catecholamines;
Children who are taking MAO inhibitors or tricyclic antidepressants
Children who are taking non-selective β-blockers such as Propranolol;
Those who are not included based on the investigators judgment.
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children
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