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A post-marketing clinical study of Xiaoer Chaiqin Qingjie Granule for acute upper respiratory infection in children

A random, double-blind and imitation, positive-drug parallel-control, multi-center clinical study to evaluate efficacy and safety of Xiaoer Chaiqin Qingjie Granule for acute upper respiratory infection( heat in both superficies and interior) in children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011035
Enrollment
Unknown
Registered
2017-03-31
Start date
2017-04-14
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

Acute upper respiratory infection( heat in both superficies and interior) in children

Interventions

Treatment Group:Xiao'er Chai Qin Granule +Xiao'er Shuangqing Granule Placebo
Control Group:Xiao'er Shuangqing Granule+ Xiao'er Chai Qin Qingjie Granule Placebo

Sponsors

Dongzhimen Hospital Beijing University of Chinese Medicine
Lead Sponsor

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; Diagnosed as Tradition Chinese Medicine syndrome with heat in both superficies and interior; 2. Aged 1 to 12 years old; 3. Disease progression within 48 hours and the highest axillary temperature =39 degree C before enrollment; 4. Signed informed consent by legal guardiansor jointly signed by the child (=10 years).

Exclusion criteria

Exclusion criteria: 1. Children with lower respiratory infections, such as bronchitis, bronchiolitis and pneumonia; 2. WBC>1.2 ULN, N>1.0 ULN or CRP>1.5 ULN, possibly have a bacterial infection; 3. Children with a history of epilepsy or hyperpyretic convulsion; 4. Children with severe malnutrition, rickets or combined with severe systemic disease such as cardiocerebral vascular system, endocrine system, Hematologic System, liver or kidney disease, etc.; 5. Children who were allergic to the test drug or its components; 6. Children who were not suitable for the clinical research according to the investigator.

Design outcomes

Primary

MeasureTime frame
Time for the main clinical symptoms( fever, dry stool) disappeared ;

Secondary

MeasureTime frame
The rate of the main clinical symptoms( fever, dry stool) disappeared;Time needed for full efervescence;Instant time for defervescence/ duration;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