A prospective non-randomized controlled clinical study evaluating the effectiveness and safety of Yuye Jiedu Granules in the treatment of children with influenza wind-heat and dampness syndrome

Phase 4

• Conditions: Childhood influenza

• Registration Number: ITMCTR2000004102
• Lead Sponsor: The 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) Meet the clinical diagnostic criteria for influenza in children, and the rapid influenza antigen test (colloidal gold immunochromatographic method) is positive;
(2) Meet the TCM syndrome differentiation standard of wind-heat and dampness;
(3) Aged from 1 to 13 years old (<14 years old);
(4) Course of fever <=48h;
(5) The informed consent process complies with the regulations, and the legal representative or the child (>=8 years old) jointly signs the informed consent form.

Exclusion Criteria

(1) Suffering from pharyngeal conjunctival fever, herpetic angina, purulent tonsillitis, etc.;
(2) Influenza complications such as sinusitis, otitis media, bronchitis, pneumonia, nervous system damage, heart damage, myositis and rhabdomyolysis, septic shock have occurred;
(3) Severe or critical cases of influenza;
(4) Antiviral drugs have been used within 48 hours before this visit;
(5) Have received influenza vaccine within 12 months before the start of the test;
(6) Receiving steroid therapy or other immunosuppressive therapy systemically;
(7) History of epilepsy or high fever convulsion;
(8) Patients with severe malnutrition, rickets, and serious primary diseases of the heart, brain, liver, kidney and hematopoietic system;
(9) Allergic to test drugs;
(10) According to the judgment of the investigator, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment, inconvenient transportation, etc. that may easily cause loss to follow-up.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Clinical recovery rate;TCM syndrome curative effect (effective rate);