Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children

September 27, 2021 updated by: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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。

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 1-6 years (>1 years, ≤6years);
  2. Children who meet the diagnosis criteria of acute bronchitis in children;
  3. All symptoms, including cough, had been present for less than 72 hours at the time of inclusion screening;
  4. The informed consent process complies with the regulations, and the legal guardian signs the informed consent.

Exclusion Criteria:

  1. 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.
  2. Children with severe bronchitis or early pneumonia;
  3. Children with acute infectious diseases such as measles, pertussis,influenza and hand-foot-and-mouth disease;
  4. Children with diseases such as acute upper respiratory tract infection, suppurative tonsillitis, wheezing bronchitis, bronchial asthma, bronchiolitis pneumonia, tuberculosis, tumor;
  5. neutrophil granulocyte>80%, or those who need antibiotic therapy;
  6. Children with severe malnutrition and immunodeficiency;
  7. Children with severe primary diseases such as heart, liver, kidney, digestion and hematopoietic system;
  8. Allergic constitution and children allergic to the drug used in this study;
  9. Children who are taking epinephrine, isoproterenol and other catecholamines;
  10. Children who are taking MAO inhibitors or tricyclic antidepressants
  11. Children who are taking non-selective β-blockers such as Propranolol;
  12. Those who are not included based on the investigators judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Xiyanping injection combined with routine treatment
Drug: Xiyanping injection
Intramuscular injection of Xiyanping injection, 0.3mL / (kg.d) daily, Bid
No Intervention: routine treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cough easing
Time Frame: up to day 7
Symptoms are less than or equal to 1 point (mild) and remain for 24 hours or more
up to day 7
Lung rales relieved
Time Frame: up to day 7
Symptoms are less than or equal to 1 point (mild) and remain for 24 hours or more
up to day 7
Fever relief
Time Frame: up to day 7
Body temperature <37.5℃ (axillary temperature) and maintained for 24h or more
up to day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QF-XYP2021-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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