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Recruiting Phase 3 NCT06715891

Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years

Trial Parameters

Condition Acute Respiratory Viral Infection
Sponsor Materia Medica Holding
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 374
Sex ALL
Min Age 3 Years
Max Age 12 Years
Start Date 2024-11-11
Completion 2027-12-31
Interventions
RaphaminPlacebo

Brief Summary

Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.

Eligibility Criteria

Inclusion Criteria: 1. Children of either gender aged 3 to12 years . 2. Diagnosis of ARVI based on the medical examination: axillary temperature ≥37.8°C at the time of examination + total severity of general symptom score ≥4 points, nasal/throat/chest symptoms ≥2 points (ARVI Symptom Severity Score). 3. 24 hours from the ARVI onset . 4. Availability of a patient information sheet and an informed consent form for the patient's parents/adopters for patient participation in the clinical trial signed by one parent/adopter of the patient. Exclusion Criteria: 1. Clinical symptoms of severe influenza/ARVI requiring hospitalization. 2. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring the administration of antibiotics from the first day of disease. 3. Suspected early manifestations of diseases that have onset symptoms similar to those of ARVI (other infectious diseases, influenza-like syndrome at the onset

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