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A post-marketed drug reassessment of Nauclea officinalis extract syrup in the treatment of acute upper respiratory tract infection in children

A post-marketed drug reassessment of Nauclea officinalis extract syrup in the treatment of acute upper respiratory tract infection in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016745
Enrollment
Unknown
Registered
2018-06-21
Start date
2018-06-06
Completion date
Unknown
Last updated
2022-01-24

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

Conditions

Acute upper respiratory tract infection (acute tonsillitis, acute pharyngitis,etc.)

Interventions

Nauclea officinalis Extract syrup group:Nil
Xiaoer Chiqiao Qingre granule group:Nil

Sponsors

West China Second University Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. diagnosis as acute upper respiratory tract infectionacute in children such as tonsillitis, acute pharyngitis; 2.Outpatients or emergency patients aged 1-14 years old(including 1-year old and 14-year old); 3. duration of disease within 48h; 4. treated with Nauclea officinalis Extract syrup or Zhiqiao Qingre granule.

Exclusion criteria

Exclusion criteria: 1. diagnose as purulent tonsillitis, bronchitis, bronchiolitis, pneumonia and other lower respiratory tract infections, influenza or influenza-like cases; 2. Children consider as bacterial infection with white blood cell (WBC)> 1.2 times reference value upper limit (ULN) or the absolute value of neutrophils (N) > ULN; 3. Children have history of epilepsy and recurrent respiratory infection; 4. Children with severe malnutrition, rickets, diabetes, congenital heart disease.or other severe systemic diseases such as brain, liver, kidney and hematopoietic system; 5. Children who are allergic to drugs; 6. Antiviral or similar drugs have been used before treatment; 7. According to the researcher's judgment, children who are easy to lost to follow-up.

Design outcomes

Primary

MeasureTime frame
recovery time of Major symptoms complete remission;

Secondary

MeasureTime frame
Major symptoms relief time;time to defervescence;admission rate;medication compliance;

Countries

China

Contacts

Public ContactLingli Zhang

West China Second University Hospital, Sichuan University

zhanglingli@scu.edu.cn+86 18180609838

Outcome results

None listed

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