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
Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Russian Federation
Aramil City Hospital
RECRUITING
Aramil
Gatchina Clinical Interdistrict Hospital
RECRUITING
Gatchina
City Clinical Hospital No # 9 of the Ministry of Health of the Udmurt Republic
NOT_YET_RECRUITING
Izhevsk
Kazan State Medical University/Department of Infectious Diseases
RECRUITING
Kazan'
Kazan State Medical University/Department of Internal Medicine
RECRUITING
Kazan'
First Moscow State Medical University named after I.M. Sechenov/University Clinical Hospital # 4
NOT_YET_RECRUITING
Moscow
Main Military Clinical Hospital named after Academician N.N. Burdenko/Therapeutic department
NOT_YET_RECRUITING
Moscow
LLC Persona Group of Companies
RECRUITING
Nizhny Novgorod
LLC Professorial Clinic
RECRUITING
Perm
LLC Ultrasound clinic 4D
RECRUITING
Pyatigorsk
Rostov Central District Hospital
RECRUITING
Rostov-on-don
City Polyclinic # 112
RECRUITING
Saint Petersburg
City Polyclinic # 3
RECRUITING
Saint Petersburg
City Polyclinic # 34
RECRUITING
Saint Petersburg
City Polyclinic # 4
RECRUITING
Saint Petersburg
City Polyclinic # 44
RECRUITING
Saint Petersburg
Institute of Experimental Medicine
NOT_YET_RECRUITING
Saint Petersburg
LLC Energy of Health
RECRUITING
Saint Petersburg
LLC Medical Center Reavita Med St. Petersburg
RECRUITING
Saint Petersburg
LLC Medical Clinic
RECRUITING
Saint Petersburg
LLC Meili
RECRUITING
Saint Petersburg
LLC Starry Clinic
RECRUITING
Saint Petersburg
LLC YAKUSI Clinic
RECRUITING
Saint Petersburg
Pokrovskaya City Hospital
RECRUITING
Saint Petersburg
St. Petersburg Research Institute of Phthisiopulmonology
RECRUITING
Saint Petersburg
Samara City Hospital # 4
RECRUITING
Samara
Samara State Medical University/Department of Infectious Diseases with Epidemiology
RECRUITING
Samara
Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy
RECRUITING
Saratov
Smolensk State Medical University/Medical and Consultative Center Academy of Health
RECRUITING
Smolensk
Scientific Medical Center of General Therapy and Pharmacology
RECRUITING
Stavropol
Ulyanovsk Regional Clinical Hospital
RECRUITING
Ulyanovsk
Voronezh Regional Clinical Hospital # 1/Pulmonology department
RECRUITING
Voronezh
LLC Medical Center for Diagnostics and Prevention Plus
RECRUITING
Yaroslavl
Contact Information
Primary
Mikhail Putilovskiy
PutilovskiyMA@materiamedica.ru
+74952761571
Time Frame
Start Date:2025-12-09
Estimated Completion Date:2028-12-31
Participants
Target number of participants:308
Treatments
Experimental: Raphamin
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.