Raphamin for acute bronchitis in adults
Official title: Multicenter, Double Blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients
Run by Materia Medica Holding · NCT07650227 · Data updated 2026-11-12
This study tests whether Raphamin helps adults with acute bronchitis feel better faster compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 308 (estimated) |
| Sponsor | Materia Medica Holding Industry-sponsored |
| Locations | 33 sites (Aramil and 32 other locations) |
| Status | Recruiting |
| Started | December 9, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | June 29, 2026 |
| Trial ID | NCT07650227 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–64 with a confirmed diagnosis of acute bronchitis, symptoms for ≤72 hours, and a baseline BSS score between 5 and 15.
✕Probably not a fit
Patients with underlying chronic lung diseases or suspected bacterial pneumonia may not benefit from this treatment and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, double-blind, placebo-controlled study in adults with acute bronchitis symptoms lasting less than 72 hours. Participants are randomized to receive Raphamin or a placebo for five days, with a specific dosing schedule on day 1 and three daily doses thereafter. The trial will track symptom resolution, disease severity, and any safety concerns, using clinical signs, blood tests, and chest imaging as needed to exclude pneumonia. Outcomes will be compared to determine if Raphamin offers a meaningful benefit over placebo in this population.
Why it matters
Potential benefit: If successful, participants taking Raphamin may experience faster symptom relief and fewer complications from acute bronchitis.
How similar studies have gone: Previous studies with similar anti-infective approaches in bronchitis have shown mixed results; this trial tests a specific agent in a rigorous, blinded design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female patients aged 18 to 64 years, inclusive. 2. Confirmed diagnosis of acute bronchitis (AB) based on the presence of productive cough and one or more symptoms (wheezing in the lungs, chest "discomfort", shortness of breath, fever). 3. The BSS score of at least 5 and no more than 15 points. 4. Duration of AB symptoms does no more than 72 hours. 5. Seasonal incidence of acute respiratory viral infections. 6. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient. 7. Patients who have agreed to use a reliable method of contraception during the study (for men and women of reproductive potential). Exclusion Criteria: 1. History of chronic obstructive pulmonary disease, chronic bronchitis, asthma, bronchiectasis, or pulmonary emphysema. 2. Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring antibiotics, starting on the first day of illness. 3. Suspected infiltrative pulmonary tuberculosis, pulmonary embolism, pulmonary infarction, drug-induced (toxic) pneumopathy, foreign body aspiration, sarcoidosis, pulmonary alveolar proteinosis, lipoid pneumonia, or atelectasis. 4. History of immunopathological diseases: systemic vasculitis, lupus pneumonitis, allergic bronchopulmonary aspergillosis, obliterating bronchiolitis, idiopathic pulmonary fibrosis, eosinophilic pneumonia, bronchocentric granulomatosis. 5. Chronic heart failure with functional classes III and IV (according to the classification of the New York Heart Association, 1964). 6. Metabolic disorders (obesity grades 2-3). 7. History of chronic kidney disease (classes C3-5 A3); liver failure (class C according to Child-Pugh); neurological conditions (neuromuscular, neurocognitive disorders, epilepsy); hemoglobinopathy. 8. Primary and/or secondary immunodeficiency (HIV infection, administration of immunosuppressive drugs, etc.). 9. Surgery of any localization within the last 3 months. 10. Clinical symptoms of severe influenza/ARI requiring hospitalization . 11. Acute respiratory failure. 12. History/suspected oncological disease of any location (except for benign neoplasms). 13. Exacerbation or decompensation of chronic diseases that affect the patient's ability to participate in the clinical trial, including diabetes mellitus. 14. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia. 15. Pregnancy, breastfeeding, and childbirth less than 3 months prior to study inclusion. 16. Hypersensitivity to any component of the medications used in the treatment. 17. Patients who have taken medications listed in the "Prohibited Concomitant Medication" section in the previous 1 month prior to study inclusion or who require medications prohibited for use in this study. 18. Patients who, in the investigator's opinion, will not comply with study monitoring requirements or with the study drugs administration schedule. 19. History of mental illness, alcoholism, or drug abuse that, in the investigator's opinion, will interfere with successful compliance with study procedures. 20. Participation in other clinical trials within 3 months prior to study inclusion. 21. The patient is a member of the center's research staff directly involved in the study and is an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children, or siblings, regardless of whether they are biological or adopted. 22. The patient is employed by NPF MATERIA MEDICA HOLDING LLC, i.e., is an employee of the company, a temporary contract worker, or a designated official responsible for the study, or is an immediate family member of one of these individuals..
Where it's running
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Aramil City Hospital
Aramil, Russia Recruiting -
Gatchina Clinical Interdistrict Hospital
Gatchina, Russia Recruiting -
Kazan State Medical University/Department of Infectious Diseases
Kazan', Russia Recruiting -
Kazan State Medical University/Department of Internal Medicine
Kazan', Russia Recruiting -
LLC "Persona Group of Companies"
Nizhny Novgorod, Russia Recruiting -
LLC "Professorial Clinic"
Perm, Russia Recruiting
Show 27 more locations
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LLC "Ultrasound clinic 4D"
Pyatigorsk, Russia Recruiting -
Rostov Central District Hospital
Rostov-on-Don, Russia Recruiting -
St. Petersburg Research Institute of Phthisiopulmonology
Saint Petersburg, Russia Recruiting -
City Polyclinic # 44
Saint Petersburg, Russia Recruiting -
LLC "Energy of Health"
Saint Petersburg, Russia Recruiting -
LLC "Medical Center "Reavita Med St. Petersburg"
Saint Petersburg, Russia Recruiting -
LLC "Medical Clinic"
Saint Petersburg, Russia Recruiting -
City Polyclinic # 112
Saint Petersburg, Russia Recruiting -
LLC "Starry Clinic"
Saint Petersburg, Russia Recruiting -
LLC "YAKUSI Clinic"
Saint Petersburg, Russia Recruiting -
City Polyclinic # 34
Saint Petersburg, Russia Recruiting -
Pokrovskaya City Hospital
Saint Petersburg, Russia Recruiting -
City Polyclinic # 3
Saint Petersburg, Russia Recruiting -
City Polyclinic # 4
Saint Petersburg, Russia Recruiting -
LLC "Meili"
Saint Petersburg, Russia Recruiting -
Samara City Hospital # 4
Samara, Russia Recruiting -
Samara State Medical University/Department of Infectious Diseases with Epidemiology
Samara, Russia Recruiting -
Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy
Saratov, Russia Recruiting -
Smolensk State Medical University/Medical and Consultative Center "Academy of Health"
Smolensk, Russia Recruiting -
Scientific Medical Center of General Therapy and Pharmacology
Stavropol, Russia Recruiting -
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russia Recruiting -
Voronezh Regional Clinical Hospital # 1/Pulmonology department
Voronezh, Russia Recruiting -
LLC "Medical Center for Diagnostics and Prevention Plus"
Yaroslavl, Russia Recruiting -
City Clinical Hospital No # 9 of the Ministry of Health of the Udmurt Republic
Izhevsk, Russia Not yet recruiting -
Main Military Clinical Hospital named after Academician N.N. Burdenko/Therapeutic department
Moscow, Russia Not yet recruiting -
First Moscow State Medical University named after I.M. Sechenov/University Clinical Hospital # 4
Moscow, Russia Not yet recruiting -
Institute of Experimental Medicine
Saint Petersburg, Russia Not yet recruiting
Study contacts
- Study coordinator: Mikhail Putilovskiy
- Email: PutilovskiyMA@materiamedica.ru
- Phone: +74952761571
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.