Actively Recruiting
The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients
Led by Materia Medica Holding · Updated on 2026-03-16
552
Participants Needed
44
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female aged 18 - 75 years
- Diagnosis of acute rhinosinusitis with 8-12 points on Major Symptom Score (MSS)
- No more than 3 severe symptoms (3 points on MSS scale)
- Facial pain or heaviness rated 1-2 points on MSS scale
- Disease duration up to 48 hours from symptom onset
- Signed informed consent form
- Agreement to use reliable contraception during the study if of reproductive potential
You will not qualify if you...
- Fever of 38.06C or higher
- Second wave of acute rhinosinusitis symptoms
- One-sided disease process
- Facial pain or pressure rated 3 points on MSS scale
- Recurrent acute rhinosinusitis (4 or more episodes per year)
- Odontogenic rhinosinusitis
- Allergic rhinitis (seasonal or year-round)
- Nasal polyps or significant nasal septum deviation
- Concomitant otitis
- Use of intranasal or systemic corticosteroids or antibiotics within 30 days
- Nasal or paranasal sinus surgery within last 6 months
- Any other surgery within last 3 months
- Severe influenza or respiratory infection requiring hospitalization
- Suspected bacterial infection needing antibiotics from disease onset
- History or suspicion of cancer except benign tumors
- Exacerbation or decompensation of chronic diseases affecting trial participation
- Diagnosed immunodeficiency of any cause
- Unstable angina or recent myocardial infarction (within 6 months)
- Severe chronic heart failure (Class III or IV)
- History of chronic kidney disease (class C3-5 A3)
- History of liver failure (Child-Pugh class C)
- Malabsorption syndrome or certain metabolic deficiencies
- Pregnancy, breastfeeding, or recent childbirth less than 3 months
- Hypersensitivity to study medication components
- Use of prohibited medications within 1 month prior to inclusion
- Inability to comply with study procedures
- History of mental illness, alcoholism, or drug abuse impacting participation
- Participation in other clinical trials within 3 months
- Related to study personnel or immediate family of investigator
- Employment with the trial sponsor or related entities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 44 locations
1
Aramil city hospital
Aramil, Russia, 624002
Active, Not Recruiting
2
Gatchina Clinical Interdistrict Hospital
Gatchina, Russia
Completed
3
Baltic Federal University named after Immanuel Kant
Kaliningrad, Russia, 236016
Actively Recruiting
4
Kazan State Medical University/Department of Infectious Diseases
Kazan', Russia, 420012
Completed
5
Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology
Krasnodar, Russia, 350063
Terminated
6
City Polyclinic # 2 of the Moscow City Department of Health
Moscow, Russia, 117556
Actively Recruiting
7
First Moscow State Medical University named after I.M. Sechenov/Department of Ear, Nose and Throat Diseases
Moscow, Russia, 119991
Completed
8
National Medical Research Center of Otolaryngology
Moscow, Russia, 123182
Actively Recruiting
9
Russian University of Medicine/Department of Otolaryngology
Moscow, Russia, 127006
Completed
10
Moscow Regional Research Clinical Institute named after M.F. Vladimirsky
Moscow, Russia, 129110
Active, Not Recruiting
11
LLC "Persona Group of Companies"
Nizhny Novgorod, Russia, 603155
Completed
12
Novosibirsk State Medical University/Department of Otolaryngology
Novosibirsk, Russia, 630091
Completed
13
LLC "Clinical and Diagnostic Center "Mediclinic"
Penza, Russia, 440071
Not Yet Recruiting
14
LLC "Professor's Clinic"
Perm, Russia, 614070
Completed
15
LLC "4D Ultrasound Clinic"
Pyatigorsk, Russia, 357502
Not Yet Recruiting
16
Rostov Central District Hospital
Rostov-on-Don, Russia, 152155
Completed
17
LLC "Otolaryngology Consultation Center"
Rostov-on-Don, Russia, 344000
Active, Not Recruiting
18
Rostov-on-Don City Hospital of Emergency Medical Care
Rostov-on-Don, Russia, 344068
Active, Not Recruiting
19
North-West State Medical University named after I.I. Mechnikov/Department of Otolaryngology
Saint Petersburg, Russia, 191015
Active, Not Recruiting
20
St. Petersburg Research Institute of Phthisiopulmonology
Saint Petersburg, Russia, 191036
Active, Not Recruiting
21
City Polyclinic # 44
Saint Petersburg, Russia, 192071
Completed
22
City Polyclinic # 109
Saint Petersburg, Russia, 192283
Active, Not Recruiting
23
LLC "Energy of Health"
Saint Petersburg, Russia, 194156
Completed
24
LLC "Medical center "Reavita Med SPb"
Saint Petersburg, Russia, 194354
Completed
25
LLC "Medical services"
Saint Petersburg, Russia, 194356
Active, Not Recruiting
26
LLC "Our Health"
Saint Petersburg, Russia, 195272
Not Yet Recruiting
27
LLC "Zvezdnaya Clinic"
Saint Petersburg, Russia, 196158
Completed
28
First Saint Petersburg State Medical University named after I.P. Pavlov/Department of Otolaryngology with clinic
Saint Petersburg, Russia, 197022
Completed
29
City Polyclinic # 34
Saint Petersburg, Russia, 197198
Completed
30
Institute of Experimental Medicine
Saint Petersburg, Russia, 197376
Completed
31
City Polyclinic # 106
Saint Petersburg, Russia, 198328
Completed
32
City Pokrovskaya Hospital
Saint Petersburg, Russia, 199106
Active, Not Recruiting
33
LLC "Meili"
Saint Petersburg, Russia, 199406
Active, Not Recruiting
34
Medical University "Reaviz"
Samara, Russia, 443001
Active, Not Recruiting
35
Samara State Medical University/Department of Otolaryngology
Samara, Russia, 443099
Completed
36
Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy
Saratov, Russia, 410012
Active, Not Recruiting
37
LLC "Uromed"
Smolensk, Russia, 214031
Completed
38
LLC "Scientific Medical Center of General Therapy and Pharmacology"
Stavropol, Russia, 355000
Active, Not Recruiting
39
Bashkir State Medical University/Department of Internal Medicine
Ufa, Russia, 450008
Completed
40
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russia, 432017
Completed
41
LLC "Dr. Bogorodskaya's Clinic of Modern Medicine"
Yaroslavl, Russia, 150001
Active, Not Recruiting
42
Clinical Hospital # 2
Yaroslavl, Russia, 150030
Active, Not Recruiting
43
LLC "Medical center for diagnostics and prevention plus"
Yaroslavl, Russia, 150040
Actively Recruiting
44
Ural State Medical University/Department of Surgical Dentistry, Otorhinolaryngology and Maxillofacial Surgery
Yekaterinburg, Russia, 620028
Withdrawn
Research Team
M
Mikhail Putilovskiy, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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