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

Qingfeng Pharmaceutical

Status

Unknown

Conditions

Acute Bronchitis in Children

Treatments

Drug: Xiyanping injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT04926506

QF-XYP2021-1

Details and patient eligibility

About

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。

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

1 to 6 years old

Volunteers

No Healthy Volunteers

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.