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

NCT ID: NCT04926506

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-08
• Study Completion Date: 2022-12-30

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.

Conditions

Acute Bronchitis in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Xiyanping injection combined with routine treatment

Group Type: EXPERIMENTAL

Xiyanping injection

Intervention Type: DRUG

Intramuscular injection of Xiyanping injection, 0.3mL / (kg.d) daily, Bid

routine treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Xiyanping injection

Intramuscular injection of Xiyanping injection, 0.3mL / (kg.d) daily, Bid

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

QF-XYP2021-1

Identifier Type: -

Identifier Source: org_study_id