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

NCT04926506 | Unknown

• 1 other identifier: QF-XYP2021-1
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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。

Conditions

Acute Bronchitis in Children

Outcome Measures

Primary Outcomes (1)

• 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

  up to day 7

Secondary Outcomes (3)

• Cough easing

  up to day 7

• Lung rales relieved

  up to day 7

• Fever relief

  up to day 7

Study Arms (2)

Xiyanping injection combined with routine treatment

EXPERIMENTAL

Drug: Xiyanping injection

routine treatment

NO INTERVENTION

Interventions

Xiyanping injection DRUG

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

Xiyanping injection combined with routine treatment

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 1-6 years (\>1 years, ≤6years);
• Children who meet the diagnosis criteria of acute bronchitis in children;
• The informed consent process complies with the regulations, and the legal guardian signs the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 15, 2021
• Study Start: October 8, 2021
• Primary Completion: September 21, 2022
• Study Completion: December 30, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-06