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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009684
Enrollment
Unknown
Registered
2016-10-28
Start date
2016-10-24
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Bronchitis

Interventions

1:Xiyanping injection
2: blank control

Sponsors

West China Second Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 3 Years

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of pediatric bronchitis with hospital treatment needed; Males and female subjects aged between 1 and 3 years old; 2. With fever, cough, gasp and expectoration symptoms; 3. Have wheeze and/ or mid-fine rales on one's lungs; 4. White blood cell count < 12 x 10^9/L, categorized priority to leukocyte; 5. C-reactive protein=8mg/L or normal Super C- reactive protein; 6. Had experienced =48 hours course before enrollment; 7. Previous Wheezing episodes=2; 8. Written informed consent.

Exclusion criteria

Exclusion criteria: Participants with severe clinical symptoms, meet any of the following 1. 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; 4. Acute infectious disease such as measles, pertussis and influenza; 5. Participants with bronchial asthma, bronchopneumonia and other respiratory diseases. Chronic lung diseases: 6. Participants with complicated pyopneumothorax, airway obstruction, toxic encephalopathy, cardiac failure or respiratory failure; 7. Participants with complicated severe underlying myocardial, liver, kidney, digestive and hematopoietic system diseases; 8. Severe malnutrition and history of immune deficiency which may seriously affect the self-limiting process of the course; 9. Participants with epilepsy and other disturbances of central nervous system; 10. Participants with congenital diseases and psychosis; 11. use of any other antiviral drugs within the 2 weeks before enrollment; 12. use of systemic hormone within the 2 weeks before enrollment; 13. Participants had a history of allergic constitution and drug allergy; Allergenic to XiYanPing injection and Andrographolide 14. Participants participated in other clinical research in the last three months 15. Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason.

Design outcomes

Primary

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

Secondary

MeasureTime frame
The total efficiency rate;

Countries

China

Contacts

Public ContactLv Lang

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

bjlll@qfyy.com.cn+86 010-84682600

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026