Testing Raphamin for treating acute rhinosinusitis in adults
Official title: Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients
Run by Materia Medica Holding · NCT06901297 · Data updated 2026-11-12
This study is testing if a new medication called Raphamin can help adults with acute rhinosinusitis feel better and improve their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 552 (estimated) |
| Sponsor | Materia Medica Holding Industry-sponsored |
| Locations | 44 sites (Aramil and 43 other locations) |
| Status | Recruiting |
| Started | April 3, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT06901297 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with acute rhinosinusitis symptoms present for no more than 48 hours.
✕Probably not a fit
Patients with symptoms indicative of acute bacterial rhinosinusitis or recurrent acute rhinosinusitis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy and safety of Raphamin in treating acute rhinosinusitis in adult patients. It is a multicenter, double-blind, placebo-controlled, randomized trial involving outpatients aged 18 to 75 years who exhibit symptoms of acute rhinosinusitis within 48 hours of onset. Participants will be randomly assigned to receive either Raphamin or a placebo for five days, with symptom severity assessed using the Major Symptom Score and quality of life measured through the SNOT-22 questionnaire. The trial aims to gather comprehensive data on the treatment's effectiveness and safety.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing acute rhinosinusitis in adults.
How similar studies have gone: Other studies have shown promise in treating acute rhinosinusitis with similar approaches, but the specific use of Raphamin is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female aged 18 - 75 years. 2. Diagnosis of acute rhinosinusitis: * 8-12 points on MSS scale; * no more than 3 severe symptoms (3 points on the MSS scale) * facial pain/heaviness in the facial area 1-2 points on the MSS scale. 3. Disease duration up to 48 hours (from the onset of the first symptoms of the disease). 4. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient. 5. Patients who agreed to use a reliable method of contraception during the study (for men and women of reproductive potential). Exclusion Criteria: 1. Symptoms of acute bacterial rhinosinusitis (three or more of those below): * fever of ≥ 38.0°C; * the second wave of ARS symptoms; * one-sided process; * facial pain/pressure of 3 points (on the MSS scale). 2. Recurrent ARS (≥4 episodes of ARS per year with complete resolution of symptoms between episodes). 3. Odontogenic rhinosinusitis. 4. Allergic (seasonal or year-round) rhinitis. 5. Nasal polyps or clinically significant nasal septum deviation. 6. Concomitant otitis. 7. Use of intranasal or systemic corticosteroids for 30 days prior to the screening visit. 8. Use of intranasal or systemic antibiotics for 30 days prior to the screening visit. 9. Surgery for the nasal cavity and paranasal sinuses during the last 6 months before the screening visit. 10. Any other surgery during the last 3 months. 11. Clinical symptoms of severe influenza/ARVI requiring hospitalization. 12. Suspected bacterial infection of any localization requiring the administration of antibiotics from the first day of disease. 13. History/suspicion of oncology of any localization (except for benign neoplasms). 14. Exacerbation or decompensation of chronic diseases (diabetes mellitus, bronchial asthma, chronic bronchitis, chronic obstructive pulmonary disease, 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. 15. Previously diagnosed immunodeficiency of any etiology. 16. Unstable angina or myocardial infarction during the last 6 months. 17. Class III and IV chronic heart failure (according to the classification of the New York Heart Association, 1964). 18. History of chronic kidney disease (classes C3-5 A3). 19. History of liver failure (class C according to Child-Pugh). 20. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia. 21. Pregnancy, breast-feeding, and childbirth less than 3 months before inclusion in the trial. 22. Hypersensitivity to any component of the medicines used in the treatment. 23. Patients who used medications listed under "Prohibited Concomitant Treatment" within 1 month prior to inclusion in the trial or need medications prohibited for use in the trial. 24. Patients who, 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. 25. History of mental illness, alcoholism, drug abuse, which, from the investigator's point of view, will prevent the patient from following the trial procedures. 26. Participation in other clinical trials within 3 months prior to inclusion in this trial. 27. Patient is related to 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. 28. Patient 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.
Where it's running
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Baltic Federal University named after Immanuel Kant
Kaliningrad, Russia Recruiting -
City Polyclinic # 2 of the Moscow City Department of Health
Moscow, Russia Recruiting -
National Medical Research Center of Otolaryngology
Moscow, Russia Recruiting -
LLC "Medical center for diagnostics and prevention plus"
Yaroslavl, Russia Recruiting -
Aramil city hospital
Aramil, Russia Active not recruiting -
Gatchina Clinical Interdistrict Hospital
Gatchina, Russia Completed
Show 38 more locations
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Kazan State Medical University/Department of Infectious Diseases
Kazan', Russia Completed -
Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology
Krasnodar, Russia Terminated -
First Moscow State Medical University named after I.M. Sechenov/Department of Ear, Nose and Throat Diseases
Moscow, Russia Completed -
Russian University of Medicine/Department of Otolaryngology
Moscow, Russia Completed -
Moscow Regional Research Clinical Institute named after M.F. Vladimirsky
Moscow, Russia Active not recruiting -
LLC "Persona Group of Companies"
Nizhny Novgorod, Russia Completed -
Novosibirsk State Medical University/Department of Otolaryngology
Novosibirsk, Russia Completed -
LLC "Clinical and Diagnostic Center "Mediclinic"
Penza, Russia Not yet recruiting -
LLC "Professor's Clinic"
Perm, Russia Completed -
LLC "4D Ultrasound Clinic"
Pyatigorsk, Russia Not yet recruiting -
Rostov Central District Hospital
Rostov-on-Don, Russia Completed -
LLC "Otolaryngology Consultation Center"
Rostov-on-Don, Russia Active not recruiting -
Rostov-on-Don City Hospital of Emergency Medical Care
Rostov-on-Don, Russia Active not recruiting -
North-West State Medical University named after I.I. Mechnikov/Department of Otolaryngology
Saint Petersburg, Russia Active not recruiting -
St. Petersburg Research Institute of Phthisiopulmonology
Saint Petersburg, Russia Active not recruiting -
City Polyclinic # 44
Saint Petersburg, Russia Completed -
City Polyclinic # 109
Saint Petersburg, Russia Active not recruiting -
LLC "Energy of Health"
Saint Petersburg, Russia Completed -
LLC "Medical center "Reavita Med SPb"
Saint Petersburg, Russia Completed -
LLC "Medical services"
Saint Petersburg, Russia Active not recruiting -
LLC "Our Health"
Saint Petersburg, Russia Not yet recruiting -
LLC "Zvezdnaya Clinic"
Saint Petersburg, Russia Completed -
First Saint Petersburg State Medical University named after I.P. Pavlov/Department of Otolaryngology with clinic
Saint Petersburg, Russia Completed -
City Polyclinic # 34
Saint Petersburg, Russia Completed -
Institute of Experimental Medicine
Saint Petersburg, Russia Completed -
City Polyclinic # 106
Saint Petersburg, Russia Completed -
City Pokrovskaya Hospital
Saint Petersburg, Russia Active not recruiting -
LLC "Meili"
Saint Petersburg, Russia Active not recruiting -
Medical University "Reaviz"
Samara, Russia Active not recruiting -
Samara State Medical University/Department of Otolaryngology
Samara, Russia Completed -
Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy
Saratov, Russia Active not recruiting -
LLC "Uromed"
Smolensk, Russia Completed -
LLC "Scientific Medical Center of General Therapy and Pharmacology"
Stavropol, Russia Active not recruiting -
Bashkir State Medical University/Department of Internal Medicine
Ufa, Russia Completed -
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russia Completed -
LLC "Dr. Bogorodskaya's Clinic of Modern Medicine"
Yaroslavl, Russia Active not recruiting -
Clinical Hospital # 2
Yaroslavl, Russia Active not recruiting -
Ural State Medical University/Department of Surgical Dentistry, Otorhinolaryngology and Maxillofacial Surgery
Yekaterinburg, Russia Withdrawn
Study contacts
- Study coordinator: Mikhail Putilovskiy, MD,PhD
- Email: PutilovskiyMA@materiamedica.ru
- Phone: +74952761571
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.