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

NCT02937857 | Unknown Phase 4

• 1 other identifier: JXQF-XYP-1606
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bronchitis

Outcome Measures

Primary Outcomes (1)

• time to total score of the clinical symptoms/signs decreased more than 70% from baseline

  up to 30 days after the last Administration

Secondary Outcomes (11)

• The total efficiency rate

  Day 3 and Day 5

• Time to defervescence

  up to 30 days after the last Administration

• Day(s) of Hospital Stay

  up to 30 days after the last Administration

• Signs and Symptoms Score from baseline

  up to 30 days after the last Administration

• Antibiotic consumption

  up to 30 days after the last Administration

Study Arms (2)

Standard treatment only

ACTIVE COMPARATOR

Standard treatment only such as antiasthmatic, expectorant and antipyretic

Drug: Standard treatment only

Standard treatment+Xiyanping injection

EXPERIMENTAL

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

Drug: Standard treatment+Xiyanping injection

Interventions

Standard treatment only DRUG

standard treatment， such as antiasthmatic,expectorant,antipyretic

Also known as: antiasthmatic,expectorant,antipyretic

Standard treatment only

Standard treatment+Xiyanping injection DRUG

standard treatment+Xiyanping injection:standard treatment， such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection,0.2-0.4mL/kg/day,qd for 5 days.

Also known as: antiasthmatic,expectorant,antipyretic + Xiyanping injection

Standard treatment+Xiyanping injection

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Guangzhou women and children health care center

Guangzhou, Guangdong, 510623, China

RECRUITING

MeSH Terms

Conditions

Bronchitis

Interventions

Anti-Asthmatic Agents

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Respiratory System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Liu Han Min, professor

  Sichuan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Xiao

CONTACT

010-84682600; chenxiao@sh-qingfeng.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: October 19, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 6, 2017

Record last verified: 2016-09

Locations

CN (1)