Actively Recruiting
Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
Led by Materia Medica Holding · Updated on 2026-02-13
264
Participants Needed
30
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients of both genders aged over 6 months and under 3 years.
- Clinically confirmed diagnosis of acute viral upper respiratory tract infections during the epidemic growth of influenza and ARVI.
- Dry (non-productive) cough lasting at least 24 hours but not more than 72 hours.
- Total cough severity score of 6 or more.
- Signed patient information sheet and informed consent form by a parent or adoptive parent.
You will not qualify if you...
- Inflammatory processes in the lower respiratory tract.
- Grade III adenoid hypertrophy.
- Chronic adenoiditis.
- Postnasal drip syndrome.
- Gastroesophageal reflux.
- Bronchial asthma.
- Cystic fibrosis.
- Primary ciliary dyskinesia.
- Bronchopulmonary dysplasia.
- Malformations of the respiratory and ENT organs.
- Other chronic lung diseases.
- Primary or secondary immunodeficiency.
- Oncological disease of any localization.
- Suspected bacterial infections including pneumonia, sinusitis, or otitis media.
- Allergic rhinitis.
- Bronchial obstruction syndrome.
- Acute obstructive laryngitis (croup) and epiglottitis.
- Congenital heart defects with hypervolemia in pulmonary circulation.
- Acute respiratory failure.
- Inflammatory, degenerative, demyelinating diseases of the central nervous system, polyneuropathies, epilepsy.
- Exacerbation or decompensation of chronic diseases affecting trial participation.
- Allergy or hypersensitivity to study medication components.
- Use of prohibited medications within 4 weeks before inclusion.
- Noncompliance with study treatment or observation requirements.
- Participation in other clinical trials within 3 months prior.
- Parent or adoptive parent related to study personnel or employees of the sponsor company.
AI-Screening
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Trial Site Locations
Total: 30 locations
1
Gatchina Clinical Interdistrict Hospital
Gatchina, Russia, 188300
Actively Recruiting
2
Llc "Medlight"
Kazan', Russia, 420097
Actively Recruiting
3
Specialized Clinical Infectious Diseases Hospital
Krasnodar, Russia, 350015
Actively Recruiting
4
Central Research Institute of Epidemiology
Moscow, Russia, 111123
Actively Recruiting
5
First Moscow State Medical University named after I.M. Sechenov
Moscow, Russia, 119991
Actively Recruiting
6
Llc "Diagnosis and Vaccines"
Moscow, Russia, 129515
Withdrawn
7
LLC "Health Laboratory"
Mytishchi, Russia, 141002
Not Yet Recruiting
8
Omsk State Medical University/Department of Hospital Pediatrics with a Course of Continuing Professional Education
Omsk, Russia, 644099
Not Yet Recruiting
9
City Children's Clinical Polyclinic # 5
Perm, Russia, 614066
Actively Recruiting
10
LLC "Professor's Clinic"
Perm, Russia, 614070
Actively Recruiting
11
Clinical and diagnostic center "Health" in Rostov-on-Don
Rostov-on-Don, Russia, 344011
Actively Recruiting
12
LLC "Clinic EuroDon"
Rostov-on-Don, Russia, 344022
Not Yet Recruiting
13
Rostov State Medical University/Department of Childhood Diseases # 3
Rostov-on-Don, Russia, 344022
Actively Recruiting
14
yazan State Medical University named after Academician I.P. Pavlov/Department of Childhood Diseases with a course in hospital pediatrics
Ryazan, Russia, 390026
Not Yet Recruiting
15
Children's City Polyclinic # 44
Saint Petersburg, Russia, 191144
Actively Recruiting
16
Saint Petersburg State Pediatric University/Department of Infectious Diseases of Adults and Epidemiology
Saint Petersburg, Russia, 194100
Not Yet Recruiting
17
LLC "Zvezdnaya Clinic"
Saint Petersburg, Russia, 196158
Actively Recruiting
18
Children's City Polyclinic # 35
Saint Petersburg, Russia, 196191
Actively Recruiting
19
Federal Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency
Saint Petersburg, Russia, 197022
Actively Recruiting
20
City Polyclinic # 3
Saint Petersburg, Russia, 199155
Actively Recruiting
21
City Polyclinic # 4
Saint Petersburg, Russia, 199178
Actively Recruiting
22
Samara Regional Children's Clinical Hospital named after N.N. Ivanova
Samara, Russia, 443079
Actively Recruiting
23
Samara State Medical University/Department of Hospital Pediatrics
Samara, Russia, 443099
Withdrawn
24
National Research Mordovian State University named after N.P. Ogarev/Department of Pediatrics
Saransk, Russia, 430005
Actively Recruiting
25
Saratov City Children's Clinical Hospital
Saratov, Russia, 410064
Withdrawn
26
Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics
Ufa, Russia, 450008
Actively Recruiting
27
Yaroslavl State Medical University/Department of Pediatrics, INPO
Yaroslavl, Russia, 150000
Actively Recruiting
28
Clinical Hospital # 2
Yaroslavl, Russia, 150030
Actively Recruiting
29
Children's City Clinical Hospital # 11
Yekaterinburg, Russia, 620028
Actively Recruiting
30
Ural State Medical University/Department of Infectious Diseases, Phthisiology and Pulmonology
Yekaterinburg, Russia, 620028
Actively Recruiting
Research Team
M
Mikhail Putilovskiy, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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