Clinical trial NCT04926506: Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children
Official title: Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children: a Multicenter, Randomized, Parallel Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Bronchitis in Children
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total clinical effective rate
timeFrame: up to day 7
Secondary outcomes:
measure: Cough easing
timeFrame: up to day 7
measure: Lung rales relieved
timeFrame: up to day 7
measure: Fever relief
timeFrame: up to day 7
Other outcomes:
Locations:
Study officials:
References: