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Efficacy and safety of intramuscular injection of Xiyanping injection in the treatment of acute bronchitis in children: a multicenter, randomized, parallel controlled clinical study

Efficacy and safety of intramuscular injection of Xiyanping injection in the treatment of acute bronchitis in children: a multicenter, randomized, parallel controlled clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046977
Enrollment
Unknown
Registered
2021-06-06
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute bronchitis in children

Interventions

Experimental group:Xiyanping injection combined with routine treatment
Control group:routine treatment

Sponsors

Jiangxi Provincial Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.Aged 1 to 6 years; 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

Exclusion criteria: 1.Within 72 hours, Chinese medicine injection and oral preparation containing andrographolide and Chinese medicine injection with similar functions (clearing heat and detoxification, cough and dysentery) were administered. 2.Children with severe bronchitis or early pneumonia; 3.Children with acute infectious diseases such as measles,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 ß-blockers such as Propranolol; 12.Those who are not included based on the investigators judgment.

Design outcomes

Primary

MeasureTime frame
Total clinical effective rate;

Secondary

MeasureTime frame
Cough relief time;Lung rale remission time;Fever remission time;

Countries

China

Contacts

Public ContactChenqiang

Jiangxi Provincial Children's Hospital

13907099745@163.com+86 13907099745

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026