RecruitingPhase 3NCT06715891
Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Respiratory Viral Infection in Children Aged 3-12 Years
Sponsor
Materia Medica Holding
Enrollment
374 participants
Start Date
Nov 11, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.
Eligibility
Min Age: 3 YearsMax Age: 12 Years
Inclusion Criteria4
- Children of either gender aged 3 to12 years .
- 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).
- hours from the ARVI onset .
- 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 Criteria15
- Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- 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.
- Suspected early manifestations of diseases that have onset symptoms similar to those of ARVI (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue diseases and other pathologies).
- Patients who require administration of antiviral medications that are prohibited for use in this trial.
- History or prior diagnosis of primary and secondary immunodeficiency.
- History/suspicion of oncology of any localization (except for benign neoplasms).
- Exacerbation or decompensation of chronic diseases (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ENT organs, etc.) affecting the patient's ability to participate in the clinical trial.
- Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- Allergy/hypersensitivity to any component of the medicines used in the treatment.
- Use of medications listed under "Prohibited Concomitant Treatment" within 2 weeks prior to inclusion in the trial.
- Patients whose parents/adopters, from the investigator's point of view, will not comply with the observation requirements during the trial or follow the procedure for taking the test drugs.
- History of mental illness of the patient (except for attention deficit hyperactivity disorder), parents/adopters of the patient.
- Participation in other clinical trials within 3 months prior to inclusion in this trial.
- A patient's parent/adopter is related to any of the on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.
- The patient's parent/adopter is employed by OOO "NPF "MATERIA MEDICA HOLDING", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.
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Interventions
DRUGRaphamin
Tablet for oral use.
DRUGPlacebo
Tablet for oral use.
Locations(35)
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NCT06715891