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

RecruitingPhase 3Ages 3 Years - 12 YearsAllMateria Medica Holding
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 of systemic connective tissue diseases and other pathologies). 4. Patients who require administration of antiviral medications that are prohibited for use in this trial. 5. History or prior diagnosis of primary and secondary immunodeficiency. 6. History/suspicion of oncology of any localization (except for benign neoplasms). 7. 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. 8. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia. 9. Allergy/hypersensitivity to any component of the medicines used in the treatment. 10. Use of medications listed under "Prohibited Concomitant Treatment" within 2 weeks prior to inclusion in the trial. 11. 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. 12. History of mental illness of the patient (except for attention deficit hyperactivity disorder), parents/adopters of the patient. 13. Participation in other clinical trials within 3 months prior to inclusion in this trial. 14. 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. 15. 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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What it tests

  • Raphamin
  • Placebo
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Where

35 sites
Gatchina Clinical Interdistrict Hospital
Gatchina, Russia
Kazan State Medical University/Department of Hospital Pediatrics
Kazan', Russia
LLC "MedLight"
Kazan', Russia
Regional Clinical Hospital # 2
Krasnodar, Russia
Specialized Clinical Infectious Diseases Hospital
Krasnodar, Russia
Central Research Institute of Epidemiology/Clinical Department of Infectious Pathology
Moscow, Russia
Morozovskaya Children's City Clinical Hospital of the Moscow City Health Department
Moscow, Russia
First Moscow State Medical University named after I.M. Sechenov/Department of Childhood Diseases
Moscow, Russia

…and 27 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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