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A randomized controlled multi-center trial for Xiao'er Jin Qiao granules in the treatment of influenza(wind heat syndromes) in child

A randomized controlled multi-center trial for Xiao'er Jin Qiao granules in the treatment of influenza(wind heat syndromes) in child

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020177
Enrollment
Unknown
Registered
2018-12-19
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

influenza

Interventions

Experimental group:Xiaoer Jinqiao granules
control group:OseltamivirPhosphateGranules

Sponsors

First Affiliated Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the influenza standard for children; 2. With the TCM symptoms of wind heat syndrome; 3. Aged 1-13(<14) years old; 4. With course of disease<=48 hours the highest axillary temperature 38 degree C or higher; 5. The informed consent process complies with the requirement,and the legal representative or the child (= 8 years old) sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed as pharyngeal binding membrane heat,benign croupous angina,tonsillitis,etc; 2. Complications have turned up, such as sinusitis, otitis media, bronchitis and so on; 3. Severe or critical cases of influenza; 4. Antiviral drugs were used within 48 hours before this visit; 5. Influenza vaccination within 12 months prior to the start of the trial; 6. Receiving steroid therapy or other immunosuppressive therapy systematically; 7. Having a history of epilepsy or febrile convulsion, recurrent respiratory tract infection; 8. Patients with Severe malnutrition, rickets and concurrent cardiovascular, liver, kidney, brain, and hematopoietic system, etc.; 9. Allergic to the test drug or allergic constitution (allergic to two or more kinds of food or drug); 10. According to the judgment of the investigators, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment and inconvenient transportation, which are easy to cause withdraw.

Design outcomes

Primary

MeasureTime frame
Clinical recovery time;

Secondary

MeasureTime frame
Time of Completely antifebrile;AUC of CARIFS symptom dimension score and time;

Countries

China

Contacts

Public ContactSi-yuan HU

First Affiliated Hospital of Tianjin University of TCM

husiyuan1963@sina.com+86 022-27986262

Outcome results

None listed

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