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RECRUITING
NCT07650227
PHASE3

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

Sponsor: Materia Medica Holding

View on ClinicalTrials.gov

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

Interventions

DRUG

Raphamin

Oral administration

DRUG

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