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

Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children: a Multicenter, Randomized, Parallel Controlled Clinical Study

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。

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Bronchitis in Children
• Intervention / Treatment: Drug: Xiyanping 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xiyanping injection combined with routine treatment	Drug: Xiyanping injection; Intramuscular injection of Xiyanping injection, 0.3mL / (kg.d) daily, Bid
No Intervention: routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough easing	Symptoms are less than or equal to 1 point (mild) and remain for 24 hours or more	up to day 7
Lung rales relieved	Symptoms are less than or equal to 1 point (mild) and remain for 24 hours or more	up to day 7
Fever relief	Body temperature <37.5℃ (axillary temperature) and maintained for 24h or more	up to day 7

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 8, 2021
• Primary Completion (Anticipated): September 21, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Acute Disease; Bronchitis
• Other Study ID Numbers: QF-XYP2021-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No