A multi - center, randomized, double-blind, parallel-controlled trial for the efficacy and safety of Lian-hua Qing-wen granules in the treatment of influenza in childre

Phase 4

• Conditions: influenza

• Registration Number: ITMCTR1900002856
• Lead Sponsor: First Teaching Hospital of Tianjin University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patients meet the clinical diagnostic criteria for influenza;
(2) Diagnosed as heat attack lung TCM syndrome;
(3) Aged 3-14 years old;
(4) The course of fever <=48 hours, maximum axillary temperature >=38.5 degree C;
(5) Tested positive for influenza infection using a rapid influenza diagnostic test (RIDT);
(6) the informed consent process is in accordance with the provisions, and the legal representative or(and) the children (>=8 years old) co-sign the informed consent.

Exclusion Criteria

(1) Severe or critical cases of influenza, or diagnosed as pharyngeal binding membrane fever, herpetic pharyngitis, suppurative tonsillitis, etc.;
(2) Patient with influenza complications,such as sinusitis, otitis media, bronchitis and pneumonia;
(3) Antiviral drugs were used within 48 hours before the visit;
(4) Received influenza vaccine within 12 months prior to the start of the trial;
(5) Recieving systemic steroid therapy or other immunosuppressive therapy;
(6) Patient has history of epilepsy or febrile convulsion;
(7) Severe malnutrition, rickets and severe primary diseases of the heart, brain, liver, kidney and hematopoietic system;
(8) Allergic to the ingredients of experimental drugs;
(9) according to the judgment of the researcher, other diseases or conditions, such as unstable living environment and inconvenient transportation, which may reduce the possibility or complicate the inclusion, may easily lead to loss of access.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical recovery time;

Secondary Outcome Measures

Name	Time	Method
Curative effect of TCM syndrome;Time to Resolution of Fever;Rate of complications/severe/critical case;Area under the curve of CARIFS score and time;Individual symptom disappearance rate;