Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug raphamin aims to speed relief from sinus infection symptoms

NCT ID NCT06901297

Symptom relief Sponsor: Materia Medica Holding Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether the drug Raphamin can quickly improve symptoms of acute rhinosinusitis (sinus infection) in adults. About 552 participants will receive either Raphamin or a placebo for a few days. The main goal is to see if more people feel much better by day 4 of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Raphamin (MMH-407)
What this could lead to
If it works, this could provide a new treatment option to relieve sinus infection symptoms more quickly.
What could go wrong
This is a Phase 3 trial, but results may not show a clear benefit over placebo. The condition often improves on its own, so the added value of Raphamin is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 552 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Rhinosinusitis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Rhinosinusitis sinusitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rhinosinusitis Rhinosinusitis acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aramil city hospital

    ACTIVE_NOT_RECRUITING

    Aramil, 624002, Russia

  • Baltic Federal University named after Immanuel Kant

    RECRUITING

    Kaliningrad, 236016, Russia

  • Bashkir State Medical University/Department of Internal Medicine

    COMPLETED

    Ufa, 450008, Russia

  • City Pokrovskaya Hospital

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 199106, Russia

  • City Polyclinic # 106

    COMPLETED

    Saint Petersburg, 198328, Russia

  • City Polyclinic # 109

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 192283, Russia

  • City Polyclinic # 2 of the Moscow City Department of Health

    RECRUITING

    Moscow, 117556, Russia

  • City Polyclinic # 34

    COMPLETED

    Saint Petersburg, 197198, Russia

  • City Polyclinic # 44

    COMPLETED

    Saint Petersburg, 192071, Russia

  • Clinical Hospital # 2

    ACTIVE_NOT_RECRUITING

    Yaroslavl, 150030, Russia

  • First Moscow State Medical University named after I.M. Sechenov/Department of Ear, Nose and Throat Diseases

    COMPLETED

    Moscow, 119991, Russia

  • First Saint Petersburg State Medical University named after I.P. Pavlov/Department of Otolaryngology with clinic

    COMPLETED

    Saint Petersburg, 197022, Russia

  • Gatchina Clinical Interdistrict Hospital

    COMPLETED

    Gatchina, Russia

  • Institute of Experimental Medicine

    COMPLETED

    Saint Petersburg, 197376, Russia

  • Kazan State Medical University/Department of Infectious Diseases

    COMPLETED

    Kazan', 420012, Russia

  • Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology

    TERMINATED

    Krasnodar, 350063, Russia

  • LLC "4D Ultrasound Clinic"

    NOT_YET_RECRUITING

    Pyatigorsk, 357502, Russia

  • LLC "Clinical and Diagnostic Center "Mediclinic"

    NOT_YET_RECRUITING

    Penza, 440071, Russia

  • LLC "Dr. Bogorodskaya's Clinic of Modern Medicine"

    ACTIVE_NOT_RECRUITING

    Yaroslavl, 150001, Russia

  • LLC "Energy of Health"

    COMPLETED

    Saint Petersburg, 194156, Russia

  • LLC "Medical center "Reavita Med SPb"

    COMPLETED

    Saint Petersburg, 194354, Russia

  • LLC "Medical center for diagnostics and prevention plus"

    RECRUITING

    Yaroslavl, 150040, Russia

  • LLC "Medical services"

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 194356, Russia

  • LLC "Meili"

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 199406, Russia

  • LLC "Otolaryngology Consultation Center"

    ACTIVE_NOT_RECRUITING

    Rostov-on-Don, 344000, Russia

  • LLC "Our Health"

    NOT_YET_RECRUITING

    Saint Petersburg, 195272, Russia

  • LLC "Persona Group of Companies"

    COMPLETED

    Nizhny Novgorod, 603155, Russia

  • LLC "Professor's Clinic"

    COMPLETED

    Perm, 614070, Russia

  • LLC "Scientific Medical Center of General Therapy and Pharmacology"

    ACTIVE_NOT_RECRUITING

    Stavropol, 355000, Russia

  • LLC "Uromed"

    COMPLETED

    Smolensk, 214031, Russia

  • LLC "Zvezdnaya Clinic"

    COMPLETED

    Saint Petersburg, 196158, Russia

  • Medical University "Reaviz"

    ACTIVE_NOT_RECRUITING

    Samara, 443001, Russia

  • Moscow Regional Research Clinical Institute named after M.F. Vladimirsky

    ACTIVE_NOT_RECRUITING

    Moscow, 129110, Russia

  • National Medical Research Center of Otolaryngology

    RECRUITING

    Moscow, 123182, Russia

  • North-West State Medical University named after I.I. Mechnikov/Department of Otolaryngology

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 191015, Russia

  • Novosibirsk State Medical University/Department of Otolaryngology

    COMPLETED

    Novosibirsk, 630091, Russia

  • Rostov Central District Hospital

    COMPLETED

    Rostov-on-Don, 152155, Russia

  • Rostov-on-Don City Hospital of Emergency Medical Care

    ACTIVE_NOT_RECRUITING

    Rostov-on-Don, 344068, Russia

  • Russian University of Medicine/Department of Otolaryngology

    COMPLETED

    Moscow, 127006, Russia

  • Samara State Medical University/Department of Otolaryngology

    COMPLETED

    Samara, 443099, Russia

  • Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy

    ACTIVE_NOT_RECRUITING

    Saratov, 410012, Russia

  • St. Petersburg Research Institute of Phthisiopulmonology

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 191036, Russia

  • Ulyanovsk Regional Clinical Hospital

    COMPLETED

    Ulyanovsk, 432017, Russia

  • Ural State Medical University/Department of Surgical Dentistry, Otorhinolaryngology and Maxillofacial Surgery

    WITHDRAWN

    Yekaterinburg, 620028, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.