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Study identifier: NCT07650227 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients

Condition: Bronchitis · Acute Bronchitis  ·  Sponsor: Materia Medica Holding

PhasePhase 3
Planned participants308
Who can joinAll sexes, 18 Years to 64 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where33 locations

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

The goal of this clinical trial is to learn if Raphamin works to treat acute bronchitis in adults. It will also learn about the efficacy and the safety of Raphamin. The main questions it aims to answer are: Will treatment with Rafamine contribute to a faster resolution of acute bronchitis symptoms, reduce the severity of the disease, and prevent the development of complications requiring antibacterial therapy compared to placebo therapy? Investigators will compare Raphamin to a placebo (a look-alike substance that contains no drug) to see if Raphamin works to treat acute bronchitis. Participants will: Take Raphamin or a placebo for 5 days. On the first day of treatment 8 tablets of Raphamin or a placebo 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. Face-to-face visits are planned in the trial: Visit 1 (Day 1), Visit 2 (Day 4±1), Visit 3 (Day 7±1), and a phone Visit 4 (day 14±1). The study uses an electronic patient diary (EPD) in which symptoms of acute bronchitis (cough, sputum, chest pain during coughing) are assessed daily.

This description comes directly from the study's public registry record.

Talk to the study team

Mikhail Putilovskiy  ·  +74952761571  ·  PutilovskiyMA@materiamedica.ru

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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..

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (33)

Aramil City HospitalAramil, RussiaRecruiting
Gatchina Clinical Interdistrict HospitalGatchina, RussiaRecruiting
City Clinical Hospital No # 9 of the Ministry of Health of the Udmurt RepublicIzhevsk, RussiaNot Yet Recruiting
Kazan State Medical University/Department of Infectious DiseasesKazan', RussiaRecruiting
Kazan State Medical University/Department of Internal MedicineKazan', RussiaRecruiting
Main Military Clinical Hospital named after Academician N.N. Burdenko/Therapeutic departmentMoscow, RussiaNot Yet Recruiting
First Moscow State Medical University named after I.M. Sechenov/University Clinical Hospital # 4Moscow, RussiaNot Yet Recruiting
LLC "Persona Group of Companies"Nizhny Novgorod, RussiaRecruiting
LLC "Professorial Clinic"Perm, RussiaRecruiting
LLC "Ultrasound clinic 4D"Pyatigorsk, RussiaRecruiting
Rostov Central District HospitalRostov-on-Don, RussiaRecruiting
St. Petersburg Research Institute of PhthisiopulmonologySaint Petersburg, RussiaRecruiting

+ 21 more locations — full list on the registry record.

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