Clinical trial Recruiting at 4 sites Phase 3 Interventional Ages 18 to 75

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

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment552 (estimated)
SponsorMateria Medica Holding
Industry-sponsored
Locations44 sites (Aramil and 43 other locations)
StatusRecruiting
StartedApril 3, 2025
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedMarch 16, 2026
Trial IDNCT06901297 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.