Status:
RECRUITING
The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients
Lead Sponsor:
Materia Medica Holding
Conditions:
Rhinosinusitis
Rhinosinusitis Acute
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Detailed Description
A multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial. The trial will enroll outpatients of either gender aged 18 to 75 years with clinical manifestations of acut...
Eligibility Criteria
Inclusion
- Male and female aged 18 - 75 years.
- 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.
- 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
- 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.
- Suspected bacterial infection of any localization requiring the administration of antibiotics from the first day of disease.
- History/suspicion of oncology of any localization (except for benign neoplasms).
- 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.
- Previously diagnosed immunodeficiency of any etiology.
- Unstable angina or myocardial infarction during the last 6 months.
- Class III and IV chronic heart failure (according to the classification of the New York Heart Association, 1964).
- History of chronic kidney disease (classes C3-5 A3).
- History of liver failure (class C according to Child-Pugh).
- Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- Pregnancy, breast-feeding, and childbirth less than 3 months before inclusion in the trial.
- Hypersensitivity to any component of the medicines used in the treatment.
- 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.
- 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.
- History of mental illness, alcoholism, drug abuse, which, from the investigator's point of view, will prevent the patient from following the trial procedures.
- Participation in other clinical trials within 3 months prior to inclusion in this trial.
- 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.
- 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.
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT06901297
Start Date
April 3 2025
End Date
December 31 2027
Last Update
September 11 2025
Active Locations (39)
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1
Aramil city hospital
Aramil, Russia, 624002
2
Gatchina Clinical Interdistrict Hospital
Gatchina, Russia
3
Baltic Federal University named after Immanuel Kant
Kaliningrad, Russia, 236016
4
Kazan State Medical University/Department of Infectious Diseases
Kazan', Russia, 420012