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A multicenter randomized controlled clinical study of Yinlai Decoction in the treatment of children with influenza (pulmonary and gastric heat accumulation syndrome)

Phase 1
Conditions
influenza
Registration Number
ITMCTR2100005417
Lead Sponsor
Beijing University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

?1 year old < age = 12 years old; ? Meet the diagnostic criteria and syndrome differentiation criteria of influenza; ? Duration of fever =48 hours; ? The informed consent process is in accordance with the provisions, and the legal representative or the subject child (=8 years old) signs the informed consent together; ? Novel coronavirus nucleic acid test was negative.

Exclusion Criteria

? Diseases with conjunctival pharyngeal fever, herpetic angina, suppurative tonsillitis and novel coronavirus infection that need to be identified with influenza; ? Influenza complications such as sinusitis, otitis media, bronchitis, etc.; ? Severe or critical cases of influenza; ? Antiviral drugs have been used within 48 hours before this visit; ? Positive systemic steroid therapy or other immunosuppressive therapy; ? Have a history of epilepsy or high fever convulsion, recurrent respiratory tract infection; ? Severe malnutrition, rickets children and complicated with heart, brain, liver, kidney and hematopoietic system serious primary diseases; ? to test drug allergy or allergic constitution (to two or more food or drug allergy); ? Other lesions or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment, inconvenient transportation and other conditions that may easily lead to loss of follow-up, according to the judgment of the investigator.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fever reduction rate for 48h and 72h;Time for complete fever reduction;Time of antipyretic effect;
Secondary Outcome Measures
NameTimeMethod
egative rate of influenza pathogen detection in pharyngeal swabs;Chinese medicine symptom complex score;Area under the curve of CARIFS symptom dimension score versus time;Incidence of complications, severe and critical diseases;Clinical recovery time of disease;
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