The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients
Trial Parameters
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.
Eligibility 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