The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients

NCT06901297 | Recruiting Phase 3

• 1 other identifier: MMH-407-011
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 44

Brief Summary

Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial of the efficacy and safety of Raphamin in the treatment of acute rhinosinusitis in adult patients.

Conditions

Rhinosinusitis; Rhinosinusitis Acute

Keywords

Rhinosinusitis; Acute

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with improvement of acute rhinosinusitis symptoms on day 4

  Improvement of symptoms is defined as symptom score less than or equal to 1 (i.e., mild symptoms or no symptoms) for all five main symptoms (rhinorrhea / anterior nasal discharge, postnasal drip, nasal congestion, headache, facial pain/pressure) with 2 consecutive 12-hour estimates.

  On 4 day

Secondary Outcomes (14)

• Percentage of patients with improvement of acute rhinosinusitis symptoms on day 7

  On 7 day of observation

• Change in SNOT-22 total score

  On days 1, 4 and 7

• Change in MSS total score

  From day 1 to day 14

• Change in the SNOT-22 nasal domain score

  On days 1, 4 and 7

• Percentage of patients with worsening of rhinosinusitis requiring systemic/topical antibiotics

  On 14 day

Study Arms (2)

Raphamin

EXPERIMENTAL

Per os without food. The tablet should be kept in mouth until completely dissolved. On day 1 of treatment, 8 tablets should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day. The duration of treatment is 5 days.

Drug: Raphamin

Placebo

PLACEBO COMPARATOR

Placebo using the Raphamin dosage regimen.

Drug: Placebo

Interventions

Raphamin DRUG

Oral administration

Also known as: MMH-407

Raphamin

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female aged 18 - 75 years.
• Diagnosis of acute rhinosinusitis:
• 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.
• Disease duration up to 48 hours (from the onset of the first symptoms of the disease).
• Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient.
• Patients who agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).

You may not qualify if:

• 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).
• Recurrent ARS (≥4 episodes of ARS per year with complete resolution of symptoms between episodes).
• Odontogenic rhinosinusitis.
• Allergic (seasonal or year-round) rhinitis.
• Nasal polyps or clinically significant nasal septum deviation.
• Concomitant otitis.
• Use of intranasal or systemic corticosteroids for 30 days prior to the screening visit.
• Use of intranasal or systemic antibiotics for 30 days prior to the screening visit.
• Surgery for the nasal cavity and paranasal sinuses during the last 6 months before the screening visit.
• Any other surgery during the last 3 months.
• Clinical symptoms of severe influenza/ARVI requiring hospitalization.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (44)

Aramil city hospital

Aramil, 624002, Russia

ACTIVE NOT RECRUITING

Gatchina Clinical Interdistrict Hospital

Gatchina, Russia

COMPLETED

Baltic Federal University named after Immanuel Kant

Kaliningrad, 236016, Russia

RECRUITING

Kazan State Medical University/Department of Infectious Diseases

Kazan', 420012, Russia

COMPLETED

Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology

Krasnodar, 350063, Russia

TERMINATED

City Polyclinic # 2 of the Moscow City Department of Health

Moscow, 117556, Russia

RECRUITING

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

Moscow, 119991, Russia

COMPLETED

National Medical Research Center of Otolaryngology

Moscow, 123182, Russia

RECRUITING

Russian University of Medicine/Department of Otolaryngology

Moscow, 127006, Russia

COMPLETED

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

Moscow, 129110, Russia

ACTIVE NOT RECRUITING

LLC "Persona Group of Companies"

Nizhny Novgorod, 603155, Russia

COMPLETED

Novosibirsk State Medical University/Department of Otolaryngology

Novosibirsk, 630091, Russia

COMPLETED

LLC "Clinical and Diagnostic Center "Mediclinic"

Penza, 440071, Russia

NOT YET RECRUITING

LLC "Professor's Clinic"

Perm, 614070, Russia

COMPLETED

LLC "4D Ultrasound Clinic"

Pyatigorsk, 357502, Russia

NOT YET RECRUITING

Rostov Central District Hospital

Rostov, 152155, Russia

COMPLETED

LLC "Otolaryngology Consultation Center"

Rostov-on-Don, 344000, Russia

ACTIVE NOT RECRUITING

Rostov-on-Don City Hospital of Emergency Medical Care

Rostov-on-Don, 344068, Russia

ACTIVE NOT RECRUITING

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

Saint Petersburg, 191015, Russia

ACTIVE NOT RECRUITING

St. Petersburg Research Institute of Phthisiopulmonology

Saint Petersburg, 191036, Russia

ACTIVE NOT RECRUITING

City Polyclinic # 44

Saint Petersburg, 192071, Russia

COMPLETED

City Polyclinic # 109

Saint Petersburg, 192283, Russia

ACTIVE NOT RECRUITING

LLC "Energy of Health"

Saint Petersburg, 194156, Russia

COMPLETED

LLC "Medical center "Reavita Med SPb"

Saint Petersburg, 194354, Russia

COMPLETED

LLC "Medical services"

Saint Petersburg, 194356, Russia

ACTIVE NOT RECRUITING

LLC "Our Health"

Saint Petersburg, 195272, Russia

NOT YET RECRUITING

LLC "Zvezdnaya Clinic"

Saint Petersburg, 196158, Russia

COMPLETED

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

Saint Petersburg, 197022, Russia

COMPLETED

City Polyclinic # 34

Saint Petersburg, 197198, Russia

COMPLETED

Institute of Experimental Medicine

Saint Petersburg, 197376, Russia

COMPLETED

City Polyclinic # 106

Saint Petersburg, 198328, Russia

COMPLETED

City Pokrovskaya Hospital

Saint Petersburg, 199106, Russia

ACTIVE NOT RECRUITING

LLC "Meili"

Saint Petersburg, 199406, Russia

ACTIVE NOT RECRUITING

Medical University "Reaviz"

Samara, 443001, Russia

ACTIVE NOT RECRUITING

Samara State Medical University/Department of Otolaryngology

Samara, 443099, Russia

COMPLETED

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

Saratov, 410012, Russia

ACTIVE NOT RECRUITING

LLC "Uromed"

Smolensk, 214031, Russia

COMPLETED

LLC "Scientific Medical Center of General Therapy and Pharmacology"

Stavropol, 355000, Russia

ACTIVE NOT RECRUITING

Bashkir State Medical University/Department of Internal Medicine

Ufa, 450008, Russia

COMPLETED

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432017, Russia

COMPLETED

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

Yaroslavl, 150001, Russia

ACTIVE NOT RECRUITING

Clinical Hospital # 2

Yaroslavl, 150030, Russia

ACTIVE NOT RECRUITING

LLC "Medical center for diagnostics and prevention plus"

Yaroslavl, 150040, Russia

RECRUITING

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

Yekaterinburg, 620028, Russia

WITHDRAWN

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Mikhail Putilovskiy, MD,PhD

CONTACT

+74952761571; PutilovskiyMA@materiamedica.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, randomized, parallel-group

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 28, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

RU (44)