A Phase 3 interventional study of Raphamin and Placebo in Rhinosinusitis and Rhinosinusitis Acute, sponsored by Materia Medica Holding. Recruiting at 44 sites in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Materia Medica Holding · Phase 3, Interventional, and Treatment
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.
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 acute rhinosinusitis (ARS) within the first 48 hours after the disease onset. Patient recruitment will be conducted during the seasonal incidence of acute respiratory viral infection (ARVI). After the patient signs the information sheet and informed consent form for participation in the clinical trial, the medical history will be collected, thermometry, objective examination, laboratory tests will be performed, concomitant diseases and concomitant therapy will be recorded. The severity of ARS symptoms will be assessed using Major Symptom Score (MSS). Initially (Day 1) and on Visits 2 (Day 4) and 3 (Day 7), the patient together with the investigator, fills in the MSS scale and completes the Sino-Nasal Outcome Test questionnaire for assessing the quality of life of patients with diseases of the nose and paranasal sinuses (SNOT-22).
If all inclusion criteria are met and there no any exclusion criteria, at Visit 1 (Day 1), the patient is randomized into one of two groups: Group 1 patients will receive Raphamin according to the dosage regimen for 5 days; Group 2 patients will receive Placebo using the Raphamin dosage regimen for 5 days.
The trial uses an electronic patient diary (EPD) where the patient daily morning and evening will make records axillary body temperature (measured with a classic mercury-free thermometer) and symptoms of the disease (according to the MSS). In addition, administration of basic therapy drugs (if applicable) as well as any possible worsening of the patient's condition (if applicable, to assess safety / to record adverse events) should also be recorded in the patient diary. The investigator will instruct the patient on how to complete the diary. At Visit 1, the patient will record the severity of ARS symptoms and body temperature in the diary together with the physician.
The patient will be observed for 14 days (screening, randomization - up to 1 day, treatment - 5 days, follow-up - up to 14 days).
During the treatment and follow-up period, patients/physicians will pay 3 visits, on days 1, 4 and 7 (Visits 1, 2 and 3) - at a medical center or at home; a phone visit (Visit 4) will be on day 14.
At Visits 2 and 3, the investigator performs objective examination, records changes in the disease symptoms, concomitant therapy, and controls the filling of the diary, evaluates the patient's compliance (Visit 3). At Visit 4 (a phone visit), the investigator evaluates safety, collects information about the patient's condition, the presence/absence of complications, the use of antibiotics, and the presence/absence of hospitalization of the patient.
Symptomatic therapy and therapy for concomitant diseases will be permitted during the trial except for the drugs listed under "Prohibited Concomitant Treatment".
251 studies on the registry are indexed under Rhinosinusitis; 69 are open to participants now.
This study's planned enrollment of 552 is above the median of 74 across 177 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →Materia Medica Holding is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of acute rhinosinusitis:
Exclusion Criteria:
Symptoms of acute bacterial rhinosinusitis (three or more of those below):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Per os without food. The tablet should be kept in mouth until completely dissolved. On day 1 of treatment, 8 tablets should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day. The duration of treatment is 5 days.
Drug: Raphamin
Placebo using the Raphamin dosage regimen.
Drug: Placebo
Oral administration
Also known as: MMH-407
Oral administration
Percentage of patients with improvement of acute rhinosinusitis symptoms on day 4
Improvement of symptoms is defined as symptom score less than or equal to 1 (i.e., mild symptoms or no symptoms) for all five main symptoms (rhinorrhea / anterior nasal discharge, postnasal drip, nasal congestion, headache, facial pain/pressure) with 2 consecutive 12-hour estimates.
Time frame: On 4 day
Percentage of patients with improvement of acute rhinosinusitis symptoms on day 7
Improvement of symptoms is defined as symptom score less than or equal to 1 (i.e., mild symptoms or no symptoms) for all five main symptoms (rhinorrhea / anterior nasal discharge, postnasal drip, nasal congestion, headache, facial pain/pressure) with 2 consecutive 12-hour estimates.
Time frame: On 7 day of observation
Change in SNOT-22 total score
Change in the Sino-Nasal Outcome Test (SNOT-22) total score from baseline to days 4 and 7 of observation. 22 symptoms are assessed. Symptom severity is rated on a scale of 0 to 5 (0 - no problem, 1 - very mild problem, 2 - mild or slight problem, 3 - moderate problem, 4 - severe problem, 5 - as bad as it gets). The maximum SNOT-22 score is 110.
Time frame: On days 1, 4 and 7
Change in MSS total score
Based on patient dairy. Change in MSS total score daily from baseline to day 14 of observation. Five main symptoms are assessed: runny nose/anterior nasal discharge, postnasal drip (need to cough mucus from the throat), nasal congestion, headache, facial pain/heaviness). The severity of symptoms is assessed in points from 0 to 3 (0 - none, 1 - mild, 2 - moderate, 3 - severe). The maximum total MSS score is 15 points. The total MSS score should not be less than 8 and not more than 12 points (inclusion criterion).
Time frame: From day 1 to day 14
Change in the SNOT-22 nasal domain score
Change in the SNOT-22 nasal domain score from baseline to days 4 and 7 of observation.
Time frame: On days 1, 4 and 7
Percentage of patients with worsening of rhinosinusitis requiring systemic/topical antibiotics
Percentage of patients with worsening of rhinosinusitis requiring systemic/topical antibiotics. Based on medical records.
Time frame: On 14 day
Proportion of patients hospitalized due to worsening rhinosinusitis
Proportion of patients hospitalized due to worsening rhinosinusitis. Based on medical records.
Time frame: On 14 day
Percentage of patients with prolonged rhinosinusitis
The percentage of patients with prolonged rhinosinusitis (main symptoms of the disease persisting for more than 7 days, progression of symptoms). Prolonged rhinosinusitis is defined as the persistence of the main symptoms of the disease, the progression of symptoms for more than 7 days, namely, the presence of the MSS symptoms rated as 2 or more points for one or more symptoms.
Time frame: On 14 day
Number of Participants With Adverse Events (AEs)
Presence and nature of adverse events during therapy. Registration of AEs begins after the first dose of the study drug, continues throughout the entire period of study therapy, and also for 24 hours after the last dose of the study drug. Based on medical records.
Time frame: From day 1 to day 14
Severity of AEs
The intensity (severity) of adverse events. Based on medical records.
Time frame: From day 1 to day 6
Causal Relationship of AEs to the Sudy Drug
The causal relationship to the study drug of adverse events. Based on medical records.
Time frame: From day 1 to day 6
Outcome of AEs
The outcome of adverse events. Based on medical records.
Time frame: From day 1 to day 6
Changes in Vital Signs (Blood Pressure)
Blood Pressure measured in mm Hg. Based on medical records.
Time frame: On days 1, 4 and 7
Changes in Vital Signs (Heart Rate)
Pulse Rate measured in beats per minute. Based on medical records.
Time frame: On days 1, 4 and 7
Changes in Vital Signs (Breathing Rate)
Respiratory Rate measured in breaths per minute. Based on medical records.
Time frame: On days 1, 4 and 7
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Started Apr 2025 (actual). Primary completion is estimated for Dec 2027, 32 months after the start.
Of 24 phase 3 interventional studies under Rhinosinusitis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 37. This study's planned 32 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: MMH-407