Actively Recruiting
Efficacy and Safety of Rengalin Liquid for Treating Cough in Children with Acute Viral Upper Respiratory Tract Infections During Influenza and ARVI Epidemics
Led by Materia Medica Holding · Updated on 2026-02-13
264
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of a liquid form of Rengalin for treating cough caused by acute viral upper respiratory tract infections in children aged 6 months to 3 years during the epidemic growth of influenza and ARVI. This randomized, double-blind, placebo-controlled trial compares Rengalin with a placebo to determine its effect on cough severity in young children. Participants will be randomly assigned to receive either 5 ml of Rengalin or a placebo orally three times a day for 7 days. The study includes initial screening and consent, followed by treatment and monitoring visits on days 1, 4, and 8, with a phone follow-up on day 14. On day 4, if needed, mucolytic ambroxol may be added while continuing the assigned study treatment. Parents will use an electronic diary to record cough severity twice daily throughout the study. During the study, researchers will assess symptoms, perform physical exams, and conduct laboratory tests including blood and urine analyses in at least half the participants. Safety and treatment adherence are closely monitored through visits and diaries. The main outcome is the percentage of patients responding to treatment by day 3, with secondary outcomes including changes in cough severity by day 7. The total study duration for participants is up to 14 days with ongoing observation.
CONDITIONS
Brief Title
Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged over 6 months and under 3 years
- Clinically confirmed acute viral upper respiratory tract infections during influenza and ARVI epidemic
- Dry (non-productive) cough lasting at least 24 hours but not more than 72 hours
- Total cough severity score of 6 or more
- Signed informed consent by a parent or adoptive parent
You will not qualify if you...
- Presence of inflammatory or chronic diseases of lower respiratory tract
- Grade III adenoid hypertrophy or chronic adenoiditis
- Postnasal drip syndrome or gastroesophageal reflux
- Bronchial asthma, cystic fibrosis, primary ciliary dyskinesia, or bronchopulmonary dysplasia
- Malformations of respiratory or ENT organs
- Primary or secondary immunodeficiency
- Any oncological disease
- Suspected bacterial infections like pneumonia, sinusitis, or otitis media
- Allergic rhinitis or bronchial obstruction syndrome
- Acute obstructive laryngitis (croup) or epiglottitis
- Congenital heart defects with pulmonary hypervolemia
- Acute respiratory failure
- Central nervous system diseases including epilepsy
- Exacerbation or decompensation of chronic diseases affecting participation
- Allergy or hypersensitivity to study medicine components
- Use of prohibited medications within 4 weeks prior to inclusion
- Inability of parent/adoptive parent to comply with study requirements
- Participation in other clinical trials within 3 months
- Parent/adoptive parent related to study personnel or employed by the sponsor company, or immediate family members thereof
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive Rengalin or placebo orally 3 times a day for 7 days to treat cough caused by viral upper respiratory tract infections.
3 visits (Visits 1, 2, and 3; in-person or at home)
Duration - Up to 14 days after treatment
Participants are observed for safety and recovery, including a telephone interview to assess cough status and any complications.
1 telephone visit (Day 14)
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
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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