A post-marketing revaluation clinical study of Xiao'er Fengreqing Mixture for acute upper respiratory infection in children

A random, double-blind and imitation, positive-drug parallel-control, multi-center clinical study on Xiao'er Fengreqing Mixture for acute upper respiratory tract infection (wind-heat cold syndrome) in children

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800014531

Enrollment

Unknown

Registered

2018-01-19

Start date

2018-02-10

Completion date

Unknown

Last updated

2018-01-29

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 (wind-heat cold syndrome) in children

Interventions

Treatment Group:Xiao'er Fengreqing Mixture+Xiao'er Baotaikang Granule Placebo

Control Group:Xiao'er Baotaikang Granule+Xiao'er Fengreqing Mixture Placebo

Eligibility

Sex/Gender

All

Age

1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as acute upper respiratory infection according to western medicine diagnostic criteria; 2. Diagnosed as Tradition Chinese Medicine syndrome with wind-heat cold syndrome; 3. Aged 1 to 12 years old; 4. Disease progression within 48 hours and the highest axillary temperature <38.5 degree Celsius before entering the group; 5. The informed consent procedure is in accordance with the provisions, and the legal representative or the child (=10 years) will sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Children with bronchitis, bronchiolitis, pneumonia and other lower respiratory tract infections; 2. WBC>1.2 ULN, N>1.0 ULN or CRP>1.5 ULN, possibly have a bacterial infection; 3. The patients were treated with traditional Chinese medicine or western medicine for the disease within 48 hours before entering the group; 4. Children with a history of epilepsy or hyperpyretic convulsion;Children with repeated respiratory infections; 5. Children with severe malnutrition, rickets or combined with other severe systemic disease such as cardiovascular , brain, liver, kidney and hematopoietic system, etc; 6. Children with mental illness; 7. Children who are allergic to experimental drugs; 8. Children who have participated in clinical trials of other drugs within three months; 9. Children who were not suitable for the clinical research according to the investigator.

Design outcomes

Primary

Measure	Time frame
Time for the main clinical symptoms(fever, stuffy nose, runny nose, sore throat, cough) disappeared;	—

Secondary

Measure	Time frame
Time needed for full defervescence;Instant time for defervescence;Efficacy for TCM syndromes;Single TCM syndromes;	—

Countries

China

Contacts

Public ContactJunhong Wang

Dongzhimen Hospital Beijing University of Chinese Medicine

jhwang3158@126.com+86 13522958051

Outcome results

None listed

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