NCT07171099

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P50-P75 for phase_3

Timeline
33mo left

Started Oct 2025

Typical duration for phase_3

Geographic Reach
1 country

30 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Oct 2025Dec 2028

First Submitted

Initial submission to the registry

July 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

October 3, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

July 14, 2025

Last Update Submit

February 11, 2026

Conditions

Cough

Keywords

CoughUpper respiratory infectionChildren from 6 months to 3 years

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients responded to treatment

    The percentage of patients responded to treatment (reduction in the total (day and night) cough severity score to 3 points or less after 3 days of treatment - isolated cough episodes or complete absence of cough during the day) after 3 days.

    On baseline and 3 day

Secondary Outcomes (1)

  • Change in the total CSS

    On baseline and 7 day

Other Outcomes (15)

  • Percentage of patients without daytime cough

    On baseline and 7 day

  • Percentage of patients with a decrease in daytime cough

    On baseline and 7 day

  • Percentage of patients without night cough

    On baseline and 7 day

  • +12 more other outcomes

Study Arms (2)

Rengalin

EXPERIMENTAL

Orally. 5 ml per dose 3 times a day for 7 days. The drug is taken without meals.

Drug: Rengalin

Placebo

PLACEBO COMPARATOR

Placebo using the dosing regimen Rengalin for 7 days.

Drug: Placebo

Interventions

RengalinDRUG

Solution for oral administration

Rengalin
PlaceboDRUG

Solution for oral administration

Placebo

Eligibility Criteria

Age6 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Inflammatory processes in the lower respiratory tract. 1.2 Grade III adenoid hypertrophy. 1.3 Chronic adenoiditis. 1.4 Postnasal drip syndrome. 1.5 Gastroesophageal reflux. 1.6 Bronchial asthma. 1.7 Cystic fibrosis. 1.8 Primary ciliary dyskinesia 1.9 Bronchopulmonary dysplasia 1.10 Malformations of the respiratory and ENT organs 1.11 Other chronic lung diseases. 1.12 Primary/secondary immunodeficiency. 1.13 Oncological disease of any localization.
  • Suspected bacterial infection of any localization, including pneumonia, sinusitis, 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 the patient's ability to participate in a clinical trial.
  • Presence of allergy/hypersensitivity to any components of the medicines used in the treatment.
  • Patients whose parents/adoptive parents, from the investigator's point of view, will not comply with observation requirements during the study or with the administration of study drugs.
  • A patient's parent/adoptive parent is related to on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.
  • The patient's parent/adoptive parent is employed by OOO "NPF "MATERIA MEDICA HOLDING", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Gatchina Clinical Interdistrict Hospital

Gatchina, 188300, Russia

RECRUITING

Llc "Medlight"

Kazan', 420097, Russia

RECRUITING

Specialized Clinical Infectious Diseases Hospital

Krasnodar, 350015, Russia

RECRUITING

Central Research Institute of Epidemiology

Moscow, 111123, Russia

RECRUITING

First Moscow State Medical University named after I.M. Sechenov

Moscow, 119991, Russia

RECRUITING

Llc "Diagnosis and Vaccines"

Moscow, 129515, Russia

WITHDRAWN

LLC "Health Laboratory"

Mytishchi, 141002, Russia

NOT YET RECRUITING

Omsk State Medical University/Department of Hospital Pediatrics with a Course of Continuing Professional Education

Omsk, 644099, Russia

NOT YET RECRUITING

City Children's Clinical Polyclinic # 5

Perm, 614066, Russia

RECRUITING

LLC "Professor's Clinic"

Perm, 614070, Russia

RECRUITING

Clinical and diagnostic center "Health" in Rostov-on-Don

Rostov-on-Don, 344011, Russia

RECRUITING

LLC "Clinic EuroDon"

Rostov-on-Don, 344022, Russia

NOT YET RECRUITING

Rostov State Medical University/Department of Childhood Diseases # 3

Rostov-on-Don, 344022, Russia

RECRUITING

yazan State Medical University named after Academician I.P. Pavlov/Department of Childhood Diseases with a course in hospital pediatrics

Ryazan, 390026, Russia

NOT YET RECRUITING

Children's City Polyclinic # 44

Saint Petersburg, 191144, Russia

RECRUITING

Saint Petersburg State Pediatric University/Department of Infectious Diseases of Adults and Epidemiology

Saint Petersburg, 194100, Russia

NOT YET RECRUITING

LLC "Zvezdnaya Clinic"

Saint Petersburg, 196158, Russia

RECRUITING

Children's City Polyclinic # 35

Saint Petersburg, 196191, Russia

RECRUITING

Federal Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency

Saint Petersburg, 197022, Russia

RECRUITING

City Polyclinic # 3

Saint Petersburg, 199155, Russia

RECRUITING

City Polyclinic # 4

Saint Petersburg, 199178, Russia

RECRUITING

Samara Regional Children's Clinical Hospital named after N.N. Ivanova

Samara, 443079, Russia

RECRUITING

Samara State Medical University/Department of Hospital Pediatrics

Samara, 443099, Russia

WITHDRAWN

National Research Mordovian State University named after N.P. Ogarev/Department of Pediatrics

Saransk, 430005, Russia

RECRUITING

Saratov City Children's Clinical Hospital

Saratov, 410064, Russia

WITHDRAWN

Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics

Ufa, 450008, Russia

RECRUITING

Yaroslavl State Medical University/Department of Pediatrics, INPO

Yaroslavl, 150000, Russia

RECRUITING

Clinical Hospital # 2

Yaroslavl, 150030, Russia

RECRUITING

Children's City Clinical Hospital # 11

Yekaterinburg, 620028, Russia

RECRUITING

Ural State Medical University/Department of Infectious Diseases, Phthisiology and Pulmonology

Yekaterinburg, 620028, Russia

RECRUITING

MeSH Terms

Conditions

CoughRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsInfections

Central Study Contacts

Mikhail Putilovskiy, MD,PhD

CONTACT

+74952761571PutilovskiyMA@materiamedica.ru

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blind, placebo-controlled, randomized, parallel-group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2025

First Posted

September 12, 2025

Study Start

October 3, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

RU(30)