Acute Bronchitis in ChildrenNCT04926506
Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children
A study testing Xiyanping injection in people with Acute Bronchitis in Children, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
Trial 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。 Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Acute Bronchitis in Children
- What is being tested?
- Xiyanping injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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
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。
Read the 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.
- Conditions
- Acute Bronchitis in Children
- Being tested
- Xiyanping injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiyanping injectionDrug
Intramuscular injection of Xiyanping injection, 0.3mL / (kg.d) daily, Bid
| Study group | Role | What they receive |
|---|---|---|
| Xiyanping injection combined with routine treatment | Experimental | Not described Receives: Drug: Xiyanping injection |
| routine treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to day 7
Secondary outcomes (3)
Cough easing
Symptoms are less than or equal to 1 point (mild) and remain for 24 hours or more
Measured: up to day 7
Lung rales relieved
Symptoms are less than or equal to 1 point (mild) and remain for 24 hours or more
Measured: up to day 7
Fever relief
Body temperature <37.5℃ (axillary temperature) and maintained for 24h or more
Measured: up to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start8 Oct 2021 (estimated)
- Primary completion21 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bronchitis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926506
- Sponsor's protocol ID
- QF-XYP2021-1
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04926506
- Acronym / sponsor ID
- QF-XYP2021-1
- Conditions
- Acute Bronchitis in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (estimated)
- Primary completion
- 21 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xiyanping injection combined with routine treatment | Experimental | Drug: Xiyanping injection |
| routine treatment | No intervention | – |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiyanping injectionIntramuscular injection of Xiyanping injection, 0.3mL / (kg.d) daily, Bid | Drug | Xiyanping injection combined with routine treatment |
Primary outcome
Total clinical effective rate
Time frame: up to day 7
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
3 secondary outcomes
Cough easing
Time frame: up to day 7
Lung rales relieved
Time frame: up to day 7
Fever relief
Time frame: up to day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Xiyanping injection in people with Acute Bronchitis in Children, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total clinical effective rate (time frame: up to day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.