An Add-on Study to Evaluate the Efficacy and Safety of Xiyanping Injection in Pediatric Bronchitis Patients.

Qingfeng Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Bronchitis

Treatments: Drug: Standard treatment+Xiyanping injection; Drug: Standard treatment only

Study type: Interventional

Funder types: Industry

Identifiers

NCT02937857

JXQF-XYP-1606

Details and patient eligibility

About

This is a multicenter, randomized, open Label,add-on study.

Full description

This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in subjects with pediatric bronchitis.

The purpose to determine the efficacy and safety of conventional treatment combined with or without Xiyanping injection in the treatment of pediatric bronchitis and to further evaluate the clinical value of Xiyanping injection in shortening the course of pediatric bronchitis

The study will enroll 240 Pediatric bronchitis volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Routine treatment for pediatric bronchitis and Xiyanping injection; volunteers from the second group will receive Routine treatment for pediatric bronchitis. Xiyanping injection will be administration as intravenous injection of 0.2-0.4mL/kg/day once daily for 5 days concomitantly with Routine treatment for pediatric bronchitis

Enrollment: 240 estimated patients

Sex: All

Ages: 1 to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of pediatric bronchitis with hospital treatment needed
• Males and female subjects
• Age between 1 and 3 years old
• With fever, cough, gasp and expectoration symptoms
• Have wheeze and/ or mid-fine rales on one's lungs
• White blood cell count < 12 x 109 / L, categorized priority to leukocyte
• C-reactive protein≤8mg/L or normal Super C- reactive protein
• Had experienced ≤48 h course before enrollment
• Previous Wheezing episodes≤2
• Written informed consent

Exclusion criteria

• Participants with severe clinical symptoms, meet any of the following：

  • SaO2≤0.92;（2）Shock or disturbance of consciousness;（3） Significantly speed up breathing , rapid pulse accompany with severe respiratory distress; or（4）Repeated occurrence of apnea or slow and irregular respiration;

• Acute infectious disease such as measles, pertussis and influenza

• Participants with bronchial asthma, bronchopneumonia and other respiratory diseases

• Chronic lung diseases

• Participants with complicated pyopneumothorax, airway obstruction, toxic encephalopathy, cardiac failure or respiratory failure

• Participants with complicated severe underlying myocardial, liver, kidney, digestive and hematopoietic system diseases

• Severe malnutrition and history of immune deficiency which may seriously affect the self-limiting process of the course

• Participants with epilepsy and other disturbances of central nervous system

• Participants with congenital diseases and psychosis

• use of any other antiviral drugs within the 2 weeks before enrollment

• use of systemic hormone within the 2 weeks before enrollment

• Participants had a history of allergic constitution and drug allergy; Allergenic to XiYanPing injection and Andrographolide

• Participants participated in other clinical research in the last three months

• Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Standard treatment only

Active Comparator group

Description:

Standard treatment only such as antiasthmatic, expectorant and antipyretic

Treatment:

Drug: Standard treatment only

Standard treatment+Xiyanping injection

Experimental group

Description:

Standard Treatment such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection intravenous administration of 0.2-0.4mL/kg/day ,QD for 5 days.

Treatment:

Drug: Standard treatment+Xiyanping injection