RecruitingPhase 3NCT07171099

Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children

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


Sponsor

Materia Medica Holding

Enrollment

264 participants

Start Date

Oct 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 MonthsMax Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Rengalin for people with cough. The study is currently recruiting participants at 30 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRengalin

Solution for oral administration

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT07171099


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