RecruitingPhase 3

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

Russia552 participantsStarted 2025-04-03

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Male and female aged 18 - 75 years.
✓. Diagnosis of acute rhinosinusitis:
✓. 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).

Exclusion criteria

✕. Symptoms of acute bacterial rhinosinusitis (three or more of those below):
✕. 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.

What they're measuring

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

Timeframe: On 4 day

Trial details

NCT IDNCT06901297

SponsorMateria Medica Holding

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Mikhail Putilovskiy, MD,PhD

+74952761571 PutilovskiyMA@materiamedica.ru

View on ClinicalTrials.gov More Rhinosinusitis trials