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Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients
Sponsor: Materia Medica Holding
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.
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
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
308
Start Date
2025-12-09
Completion Date
2028-12-31
Last Updated
2026-06-16
Healthy Volunteers
No
Conditions
Interventions
Raphamin
Oral administration
Placebo
Oral administration
Locations (33)
Aramil City Hospital
Aramil, Russia
Gatchina Clinical Interdistrict Hospital
Gatchina, Russia
City Clinical Hospital No # 9 of the Ministry of Health of the Udmurt Republic
Izhevsk, Russia
Kazan State Medical University/Department of Infectious Diseases
Kazan', Russia
Kazan State Medical University/Department of Internal Medicine
Kazan', Russia
Main Military Clinical Hospital named after Academician N.N. Burdenko/Therapeutic department
Moscow, Russia
First Moscow State Medical University named after I.M. Sechenov/University Clinical Hospital # 4
Moscow, Russia
LLC "Persona Group of Companies"
Nizhny Novgorod, Russia
LLC "Professorial Clinic"
Perm, Russia
LLC "Ultrasound clinic 4D"
Pyatigorsk, Russia
Rostov Central District Hospital
Rostov-on-Don, Russia
St. Petersburg Research Institute of Phthisiopulmonology
Saint Petersburg, Russia
City Polyclinic # 44
Saint Petersburg, Russia
LLC "Energy of Health"
Saint Petersburg, Russia
LLC "Medical Center "Reavita Med St. Petersburg"
Saint Petersburg, Russia
LLC "Medical Clinic"
Saint Petersburg, Russia
City Polyclinic # 112
Saint Petersburg, Russia
LLC "Starry Clinic"
Saint Petersburg, Russia
LLC "YAKUSI Clinic"
Saint Petersburg, Russia
City Polyclinic # 34
Saint Petersburg, Russia
Institute of Experimental Medicine
Saint Petersburg, Russia
Pokrovskaya City Hospital
Saint Petersburg, Russia
City Polyclinic # 3
Saint Petersburg, Russia
City Polyclinic # 4
Saint Petersburg, Russia
LLC "Meili"
Saint Petersburg, Russia
Samara City Hospital # 4
Samara, Russia
Samara State Medical University/Department of Infectious Diseases with Epidemiology
Samara, Russia
Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy
Saratov, Russia
Smolensk State Medical University/Medical and Consultative Center "Academy of Health"
Smolensk, Russia
Scientific Medical Center of General Therapy and Pharmacology
Stavropol, Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russia
Voronezh Regional Clinical Hospital # 1/Pulmonology department
Voronezh, Russia
LLC "Medical Center for Diagnostics and Prevention Plus"
Yaroslavl, Russia