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

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 thedisease).

4. Availability of a patient information sheet and an informed consent form forparticipation in the clinical trial signed by the patient.

5. Patients who agreed to use a reliable method of contraception during the study (formen 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 symptomsbetween 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 screeningvisit.

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 beforethe 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 ofantibiotics 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, bronchialasthma, chronic bronchitis, chronic obstructive pulmonary disease, cystic fibrosis,primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of therespiratory and ENT organs, etc.) affecting the patient's ability to participate inthe 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 NewYork 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 otherdisaccharidase deficiency, galactosemia.

21. Pregnancy, breast-feeding, and childbirth less than 3 months before inclusion in thetrial.

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 inthe trial.

24. Patients who, from the investigator's point of view, will not comply with theobservation requirements during the trial or follow the procedure for taking thetest drugs.

25. History of mental illness, alcoholism, drug abuse, which, from the investigator'spoint of view, will prevent the patient from following the trial procedures.

26. Participation in other clinical trials within 3 months prior to inclusion in thistrial.

27. Patient is related to on-site research personnel directly involved in the trial, oris the immediate family member of the investigator. 'Immediate family members' meanspouses, parents, children, or siblings, whether related or adopted.

28. Patient is employed by OOO "NPF "MATERIA MEDICA HOLDING", i.e., is an employee ofthe company, a temporary contract employee, or a designated official responsible forconducting the trial or their immediate family member.