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Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
Sponsor: Materia Medica Holding
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of liquid dosage form of Rengalin in the treatment of cough in acute viral upper respiratory tract infections infections in children in during the epidemic growth of influenza and ARVI. The main questions it aims to answer are: Investigators will compare the liquid dosage form of Rengalin to a placebo (a look-alike substance that contains no drug) to see if Rengalin in the liquid dosage form works for cough in acute viral upper respiratory tract infections in children. Participants will: Take the liquid dosage form of Rengalin or placebo per os 5 ml per administration 3 times a day for 7 days.
Official title: Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Rengalin in the Treatment of Cough in Acute Viral Upper Respiratory Tract Infections Tract Infections in Children During the Epidemic Growth of Influenza and ARVI
Key Details
Gender
All
Age Range
6 Months - 3 Years
Study Type
INTERVENTIONAL
Enrollment
264
Start Date
2025-10-03
Completion Date
2028-12-31
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
Rengalin
Solution for oral administration
Placebo
Solution for oral administration
Locations (30)
Gatchina Clinical Interdistrict Hospital
Gatchina, Russia
Llc "Medlight"
Kazan', Russia
Specialized Clinical Infectious Diseases Hospital
Krasnodar, Russia
Central Research Institute of Epidemiology
Moscow, Russia
First Moscow State Medical University named after I.M. Sechenov
Moscow, Russia
Llc "Diagnosis and Vaccines"
Moscow, Russia
LLC "Health Laboratory"
Mytishchi, Russia
Omsk State Medical University/Department of Hospital Pediatrics with a Course of Continuing Professional Education
Omsk, Russia
City Children's Clinical Polyclinic # 5
Perm, Russia
LLC "Professor's Clinic"
Perm, Russia
Clinical and diagnostic center "Health" in Rostov-on-Don
Rostov-on-Don, Russia
LLC "Clinic EuroDon"
Rostov-on-Don, Russia
Rostov State Medical University/Department of Childhood Diseases # 3
Rostov-on-Don, Russia
yazan State Medical University named after Academician I.P. Pavlov/Department of Childhood Diseases with a course in hospital pediatrics
Ryazan, Russia
Children's City Polyclinic # 44
Saint Petersburg, Russia
Saint Petersburg State Pediatric University/Department of Infectious Diseases of Adults and Epidemiology
Saint Petersburg, Russia
LLC "Zvezdnaya Clinic"
Saint Petersburg, Russia
Children's City Polyclinic # 35
Saint Petersburg, Russia
Federal Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency
Saint Petersburg, Russia
City Polyclinic # 3
Saint Petersburg, Russia
City Polyclinic # 4
Saint Petersburg, Russia
Samara Regional Children's Clinical Hospital named after N.N. Ivanova
Samara, Russia
Samara State Medical University/Department of Hospital Pediatrics
Samara, Russia
National Research Mordovian State University named after N.P. Ogarev/Department of Pediatrics
Saransk, Russia
Saratov City Children's Clinical Hospital
Saratov, Russia
Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics
Ufa, Russia
Yaroslavl State Medical University/Department of Pediatrics, INPO
Yaroslavl, Russia
Clinical Hospital # 2
Yaroslavl, Russia
Children's City Clinical Hospital # 11
Yekaterinburg, Russia
Ural State Medical University/Department of Infectious Diseases, Phthisiology and Pulmonology
Yekaterinburg, Russia