- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02937857
An Add-on Study to Evaluate the Efficacy and Safety of Xiyanping Injection in Pediatric Bronchitis Patients.
A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Subjects With Pediatric Bronchitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Chen Xiao
- Phone Number: 010-84682600
- Email: chenxiao@sh-qingfeng.net
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510623
- Recruiting
- Guangzhou women and children health care center
-
Contact:
- Deng Li, professor
- Phone Number: 020-38076348
- Email: drdengli@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard treatment only
Standard treatment only such as antiasthmatic, expectorant and antipyretic
|
standard treatment, such as antiasthmatic,expectorant,antipyretic
Other Names:
|
Experimental: Standard treatment+Xiyanping injection
Standard Treatment such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection intravenous administration of 0.2-0.4mL/kg/day
,QD for 5 days.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to total score of the clinical symptoms/signs decreased more than 70% from baseline
Time Frame: up to 30 days after the last Administration
|
up to 30 days after the last Administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The total efficiency rate
Time Frame: Day 3 and Day 5
|
Day 3 and Day 5
|
|
Time to defervescence
Time Frame: up to 30 days after the last Administration
|
up to 30 days after the last Administration
|
|
Day(s) of Hospital Stay
Time Frame: up to 30 days after the last Administration
|
up to 30 days after the last Administration
|
|
Signs and Symptoms Score from baseline
Time Frame: up to 30 days after the last Administration
|
up to 30 days after the last Administration
|
|
Antibiotic consumption
Time Frame: up to 30 days after the last Administration
|
check and record the usage of antibiotic,including durg Utilization Rate and the duration of usage
|
up to 30 days after the last Administration
|
Usage of Inhaled corticosteroids
Time Frame: up to 30 days after the last Administration
|
check and record the usage of Inhaled corticosteroids,including durg Utilization Rate and the duration of usage
|
up to 30 days after the last Administration
|
Incidence of complication
Time Frame: up to 30 days after the last Administration
|
record the incidence of new complication after treatment.
|
up to 30 days after the last Administration
|
Sputum status
Time Frame: up to 30 days after the last Administration
|
record the incidence of expectoration and the day of expectoration disappear
|
up to 30 days after the last Administration
|
Expenditure of therapeutic drug
Time Frame: up to 30 days after the last Administration
|
up to 30 days after the last Administration
|
|
The total expenditure of treatment
Time Frame: up to 30 days after the last Administration
|
Expenditure of treatment include the cost of durg, hospitalization,examination
|
up to 30 days after the last Administration
|
incidence of adverse events
Time Frame: up to 30 days after the last Administration
|
up to 30 days after the last Administration
|
Collaborators and Investigators
Investigators
- Principal Investigator: Liu Han Min, professor, Sichuan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JXQF-XYP-1606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bronchitis
-
Hanlim Pharm. Co., Ltd.CompletedAcute Exacerbations of Chronic Bronchitis | Acute BronchitisKorea, Republic of
-
Parc de Salut MarCompletedObstructive Chronic Bronchitis With Acute ExacerbationSpain
-
Lee's Pharmaceutical LimitedUnknownAcute Exacerbations of Chronic BronchitisChina
-
Yuhan CorporationCompletedChronic Bronchitis | Acute BronchitisKorea, Republic of
-
Neutec Ar-Ge San ve Tic A.ŞUnknownAcute Exacerbation of Chronic Bronchitis | Community-Acquired PneumoniaeTurkey
-
Gala Therapeutics, Inc.Active, not recruiting
-
Ahn-Gook Pharmaceuticals Co.,LtdCompletedBronchitis, COPDKorea, Republic of
-
Jiangxi Qingfeng Pharmaceutical Co. Ltd.UnknownAcute Exacerbation of Chronic BronchitisChina
-
PharmaKingCompletedAcute Exacerbation of Chronic BronchitisKorea, Republic of
-
Felix JF HerthUnknownObstructive Chronic Bronchitis
Clinical Trials on Standard treatment only
-
Cropper MedicalCompletedOsteoarthritis of the Knee
-
Duke UniversityRecruiting
-
University of VirginiaActive, not recruiting
-
King Fahad Armed Forces HospitalCompletedDental Decay
-
Ulthera, IncCompletedScars | StriaeUnited States
-
University Hospital, CaenCompleted
-
Linkoeping UniversityCompletedWhiplash InjuriesSweden
-
Postgraduate Institute of Dental Sciences RohtakCompletedGingival RecessionIndia
-
Vericel CorporationCompletedOsteonecrosisUnited States
-
Bangladesh Medical Research Council (BMRC)UnknownCOVID-19 | Favipiravir (Favipira)Bangladesh