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
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 3
Healthy Volunteers: f
View:
• Outpatients of both genders aged over 6 months and under 3 years.
• Clinically confirmed diagnosis of acute viral upper respiratory tract infections (acute pharyngitis, nasopharyngitis, tonsillitis, laryngitis, laryngotracheitis, tracheitis, acute viral respiratory infection of multiple and unspecified localization) during the epidemic growth of influenza and ARVI.
• Dry (non-productive) cough lasting at least 24 hours but not more than 72 hours.
• Total (day and night) cough severity score of 6 or more.
• Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by one of the patient's parents/adoptive parents.
Locations
Other Locations
Russian Federation
Gatchina Clinical Interdistrict Hospital
RECRUITING
Gatchina
Llc Medlight
RECRUITING
Kazan'
Specialized Clinical Infectious Diseases Hospital
RECRUITING
Krasnodar
Central Research Institute of Epidemiology
RECRUITING
Moscow
First Moscow State Medical University named after I.M. Sechenov
RECRUITING
Moscow
Llc Diagnosis and Vaccines
WITHDRAWN
Moscow
LLC Health Laboratory
NOT_YET_RECRUITING
Mytishchi
Omsk State Medical University/Department of Hospital Pediatrics with a Course of Continuing Professional Education
NOT_YET_RECRUITING
Omsk
City Children's Clinical Polyclinic # 5
RECRUITING
Perm
LLC Professor's Clinic
RECRUITING
Perm
Clinical and diagnostic center Health in Rostov-on-Don
RECRUITING
Rostov-on-don
LLC Clinic EuroDon
NOT_YET_RECRUITING
Rostov-on-don
Rostov State Medical University/Department of Childhood Diseases # 3
RECRUITING
Rostov-on-don
yazan State Medical University named after Academician I.P. Pavlov/Department of Childhood Diseases with a course in hospital pediatrics
NOT_YET_RECRUITING
Ryazan
Children's City Polyclinic # 35
RECRUITING
Saint Petersburg
Children's City Polyclinic # 44
RECRUITING
Saint Petersburg
City Polyclinic # 3
RECRUITING
Saint Petersburg
City Polyclinic # 4
RECRUITING
Saint Petersburg
Federal Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency
RECRUITING
Saint Petersburg
LLC Zvezdnaya Clinic
RECRUITING
Saint Petersburg
Saint Petersburg State Pediatric University/Department of Infectious Diseases of Adults and Epidemiology
NOT_YET_RECRUITING
Saint Petersburg
Samara Regional Children's Clinical Hospital named after N.N. Ivanova
RECRUITING
Samara
Samara State Medical University/Department of Hospital Pediatrics
WITHDRAWN
Samara
National Research Mordovian State University named after N.P. Ogarev/Department of Pediatrics
RECRUITING
Saransk
Saratov City Children's Clinical Hospital
WITHDRAWN
Saratov
Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics
RECRUITING
Ufa
Clinical Hospital # 2
RECRUITING
Yaroslavl
Yaroslavl State Medical University/Department of Pediatrics, INPO
RECRUITING
Yaroslavl
Children's City Clinical Hospital # 11
RECRUITING
Yekaterinburg
Ural State Medical University/Department of Infectious Diseases, Phthisiology and Pulmonology
RECRUITING
Yekaterinburg
Contact Information
Primary
Mikhail Putilovskiy, MD,PhD
PutilovskiyMA@materiamedica.ru
+74952761571
Time Frame
Start Date:2025-10-03
Estimated Completion Date:2028-12-31
Participants
Target number of participants:264
Treatments
Experimental: Rengalin
Orally. 5 ml per dose 3 times a day for 7 days. The drug is taken without meals.
Placebo_comparator: Placebo
Placebo using the dosing regimen Rengalin for 7 days.