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This is a multicenter, randomized, open Label,add-on study.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment only | Active Comparator | Standard treatment only such as antiasthmatic, expectorant and antipyretic |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard treatment only | Drug | standard treatment, such as antiasthmatic,expectorant,antipyretic |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to total score of the clinical symptoms/signs decreased more than 70% from baseline | up to 30 days after the last Administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participants with severe clinical symptoms, meet any of the following:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Xiao | Contact | 010-84682600 | chenxiao@sh-qingfeng.net |
| Name | Affiliation | Role |
|---|---|---|
| Liu Han Min, professor | Sichuan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou women and children health care center | Recruiting | Guangzhou | Guangdong | 510623 | China |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D018927 | Anti-Asthmatic Agents |
| ID | Term |
|---|---|
| D019141 | Respiratory System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| 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. |
|
|
| up to 30 days after the last Administration |
| Signs and Symptoms Score from baseline | up to 30 days after the last Administration |
| Antibiotic consumption | 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 | 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 | record the incidence of new complication after treatment. | up to 30 days after the last Administration |
| Sputum status | record the incidence of expectoration and the day of expectoration disappear | up to 30 days after the last Administration |
| Expenditure of therapeutic drug | up to 30 days after the last Administration |
| The total expenditure of treatment | Expenditure of treatment include the cost of durg, hospitalization,examination | up to 30 days after the last Administration |
| incidence of adverse events | up to 30 days after the last Administration |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |