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Xiaoer Fengreqing Oral liquid in the treatment of Childhood Influenza (Wind-Heat invading Health Syndrome)-- Randomized, double-blind, positive Drug parallel Control, multicenter Clinical trial

Randomized, double-blind, parallel-controlled, multicenter clinical trial of Xiaoer Fengreqing oral liquid in the treatment of childhood influenza (wind-heat invading health syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076191
Enrollment
Unknown
Registered
2023-09-27
Start date
2023-09-30
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

Children's influenza

Interventions

Treatment group:Xiao'er Fengreqing Oral Liquid + Oseltamivir Phosphate Granules Simulator
Positive drug control group:Oseltamivir Phosphate Granules + Xiao'er Fengreqing Oral Liquid Simulator

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Meet the Western medical diagnostic standards for childhood influenza; (2) Meet the syndrome differentiation standards of wind-heat and Wei syndrome in traditional Chinese medicine, or is accompanied by concurrent syndrome; (3) Nasopharyngeal/throat swab rapid antigen test for influenza virus is positive; (4) Aged between 1 and 14 years old (<15 years old); (5) The duration of fever to medical consultation is =48 hours, and the maximum axillary temperature is =38.0?; (6) The informed consent process should comply with regulations, and the legal guardian or the subject child (=8 years old) should jointly sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Severe or critical cases of influenza; (2) Patients combined with other respiratory tract infections such as pharyngeal conjunctival fever, herpetic angina, suppurative tonsillitis, etc.; (3) Influenza complications have occurred, including but not limited to sinusitis, otitis media, bronchitis, pneumonia, myocarditis, encephalitis, encephalopathy and other influenza complications; (4) Antiviral drugs have been used within 48 hours before this visit; (5) Currently receiving systemic steroid treatment or other immunosuppressive treatment; (6) Have a history of epilepsy or febrile convulsions, or recurrent respiratory infections; (7) Have basic diseases such as chronic respiratory, heart, kidney, liver, blood, endocrine, nervous system and immunodeficiency diseases; (8) Patients with glucose-6-phosphate dehydrogenase deficiency (favismosis); (9) Allergy to known components of the trial medication; (10) Those who the researcher believes are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Clinical recovery time;

Secondary

MeasureTime frame
Complete antipyretic time;The area under the curve of CARIFS symptom dimension score and time;TCM syndrome score / efficacy;Disappearance rate of single symptom;Incidence of complications / severe / critical influenza;Utilization rate and proportion of acetaminophen;Virus negative conversion rate;

Countries

China

Contacts

Public ContactLi Xinmin

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, No. 88, Changling Road, Xiqing District, Tianjin

tjtcmlxm@163.com+86 22 2798 6368

Outcome results

None listed

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