Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients
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
Materia Medica Holding
308 participants
Dec 9, 2025
INTERVENTIONAL
Conditions
Summary
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? Researchers 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 placibo 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.
Eligibility
Inclusion Criteria7
- Male and female patients aged 18 to 64 years, inclusive.
- 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).
- The BSS score of at least 5 and no more than 15 points.
- Duration of AB symptoms does no more than 72 hours.
- Seasonal incidence of acute respiratory viral infections.
- Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient.
- Patients who have agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).
Exclusion Criteria22
- History of chronic obstructive pulmonary disease, chronic bronchitis, asthma, bronchiectasis, or pulmonary emphysema.
- Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring antibiotics, starting on the first day of illness.
- Suspected infiltrative pulmonary tuberculosis, pulmonary embolism, pulmonary infarction, drug-induced (toxic) pneumopathy, foreign body aspiration, sarcoidosis, pulmonary alveolar proteinosis, lipoid pneumonia, or atelectasis.
- History of immunopathological diseases: systemic vasculitis, lupus pneumonitis, allergic bronchopulmonary aspergillosis, obliterating bronchiolitis, idiopathic pulmonary fibrosis, eosinophilic pneumonia, bronchocentric granulomatosis.
- Chronic heart failure with functional classes III and IV (according to the classification of the New York Heart Association, 1964).
- Metabolic disorders (obesity grades 2-3).
- History of chronic kidney disease (classes C3-5 A3); liver failure (class C according to Child-Pugh); neurological conditions (neuromuscular, neurocognitive disorders, epilepsy); hemoglobinopathy.
- Primary and/or secondary immunodeficiency (HIV infection, administration of immunosuppressive drugs, etc.).
- Surgery of any localization within the last 3 months.
- Clinical symptoms of severe influenza/ARI requiring hospitalization .
- Acute respiratory failure.
- History/suspected oncological disease of any location (except for benign neoplasms).
- Exacerbation or decompensation of chronic diseases that affect the patient's ability to participate in the clinical trial, including diabetes mellitus.
- Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- Pregnancy, breastfeeding, and childbirth less than 3 months prior to study inclusion.
- Hypersensitivity to any component of the medications used in the treatment.
- 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.
- Patients who, in the investigator's opinion, will not comply with study monitoring requirements or with the study drugs administration schedule.
- History of mental illness, alcoholism, or drug abuse that, in the investigator's opinion, will interfere with successful compliance with study procedures.
- Participation in other clinical trials within 3 months prior to study inclusion.
- 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.
- 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..
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Interventions
Oral administration
Oral administration
Locations(33)
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NCT07650227