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The efficacy and safety of Xiaoer Fei-Reqing granules in the treatment of influenza in children (heat toxicity attack lung syndrome) : a randomized double-blind parallel controlled multi-center clinical trial

The efficacy and safety of Xiaoer Fei-Reqing granules in the treatment of influenza in children (heat toxicity attack lung syndrome) : a randomized double-blind parallel controlled multi-center clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000881
Enrollment
Unknown
Registered
2024-12-28
Start date
2025-01-06
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Childhood influenza

Interventions

Control group:Oseltamivir phosphate granule and Xiaoer Feireqing granule simulator
Experimental group:Xiaoer Feireqing granule and oseltamivir phosphate granule simulator

Sponsors

The First Affiliated Hospital of Tianjin University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria (1) meet the Western medicine diagnostic criteria for childhood influenza; (2) Conforming to the syndrome differentiation standard of TCM heat toxicity attacking lung; (3) nasopharyngeal/oropharyngeal swab influenza virus rapid antigen test positive; (4) At least one single symptom of CARIFs symptom dimension was moderate or above at the time of enrollment; (5) Age 1-14 years old (< 15 years old); (6) The duration from fever to treatment was less than 72h and the maximum axillary temperature was =38.0? 24h before diagnosis; (7) The informed consent process should be in accordance with the regulations and the legal guardian or the subject child (=8 years old) should sign the informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria (1) Severe or critical influenza cases; (2) Patients with pharyngeal conjunctiva fever herpetic angina suppurative tonsillitis and other respiratory tract infections; (3) Influenza complications including but not limited to sinusitis otitis media pneumonia myocarditis encephalitis encephalopathy and other influenza complications (except bronchitis); (4) Antiviral drugs (chemicals including oseltamivir zanamivir and peramivir etc.) had been used within 72 hours prior to this visit; Traditional Chinese medicine includes Lianhua Qingwen capsule cold Qingre granule Jinhua Qinggan granule etc.); (5) is systematically receiving steroid therapy or other immunosuppressive therapy; (6) A history of epilepsy or febrile convulsions repeated respiratory infections; (7) chronic respiratory heart kidney liver blood endocrine nervous system and immune deficiencies and other underlying diseases; (8) glucose-6-phosphate dehydrogenase deficiency (broad bean disease); (9) Allergic to known components of the investigational drug product; (10) Participants considered inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Clinical recovery time;

Secondary

MeasureTime frame
Complete regression time;Incidence of complications/severe/critical influenza;Variation value/effective rate of TCM syndrome score;Disappearance rate of single symptom;Virus negative conversion rate;CARIFS symptom score change;Acetaminophen use;

Countries

China

Contacts

Public ContactRong Ping

The First Affiliated Hospital of Tianjin University of Chinese Medicine

2467755681@qq.com18032689895

Outcome results

None listed

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