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New cough syrup for toddlers under trial this flu season

NCT ID NCT07171099

Symptom relief Sponsor: Materia Medica Holding Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a liquid medicine called Rengalin can safely reduce coughing in children aged 6 months to 3 years who have a viral cold or flu. About 264 children will take either Rengalin or a placebo three times a day for 7 days. The main goal is to see if more children have much less coughing after 3 days of treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 264 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 3 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Outpatients of both genders aged over 6 months and under 3 years. 2. 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. 3. Dry (non-productive) cough lasting at least 24 hours but not more than 72 hours. 4. Total (day and night) cough severity score of 6 or more. 5. 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. Exclusion Criteria: 1. Presence of the following diseases at the time of inclusion in the clinical trial: 1.1 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. 2. Suspected bacterial infection of any localization, including pneumonia, sinusitis, otitis media. 3. Allergic rhinitis. 4. Bronchial obstruction syndrome. 5. Acute obstructive laryngitis \[croup\] and epiglottitis. 6. Congenital heart defects with hypervolemia in pulmonary circulation. 7. Acute respiratory failure. 8. Inflammatory, degenerative, demyelinating diseases of the central nervous system, polyneuropathies, epilepsy. 9. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in a clinical trial. 10. Presence of allergy/hypersensitivity to any components of the medicines used in the treatment. 11. Taking medications listed in the section "Prohibited Concomitant Therapy" within 4 weeks prior to inclusion in the study. 12. 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. 13. Participation in other clinical trials within 3 months prior to inclusion in this trial. 14. 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. 15. 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.

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Conditions

The condition(s) this trial relates to.

Cough respiratory tract infectious disorder viral respiratory tract infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cough

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics

    RECRUITING

    Ufa, 450008, Russia

  • Central Research Institute of Epidemiology

    RECRUITING

    Moscow, 111123, Russia

  • Children's City Clinical Hospital # 11

    RECRUITING

    Yekaterinburg, 620028, Russia

  • Children's City Polyclinic # 35

    RECRUITING

    Saint Petersburg, 196191, Russia

  • Children's City Polyclinic # 44

    RECRUITING

    Saint Petersburg, 191144, Russia

  • City Children's Clinical Polyclinic # 5

    RECRUITING

    Perm, 614066, Russia

  • City Polyclinic # 3

    RECRUITING

    Saint Petersburg, 199155, Russia

  • City Polyclinic # 4

    RECRUITING

    Saint Petersburg, 199178, Russia

  • Clinical Hospital # 2

    RECRUITING

    Yaroslavl, 150030, Russia

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

    RECRUITING

    Rostov-on-Don, 344011, Russia

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

    RECRUITING

    Saint Petersburg, 197022, Russia

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

    RECRUITING

    Moscow, 119991, Russia

  • Gatchina Clinical Interdistrict Hospital

    RECRUITING

    Gatchina, 188300, Russia

  • LLC "Clinic EuroDon"

    NOT_YET_RECRUITING

    Rostov-on-Don, 344022, Russia

  • LLC "Health Laboratory"

    NOT_YET_RECRUITING

    Mytishchi, 141002, Russia

  • LLC "Professor's Clinic"

    RECRUITING

    Perm, 614070, Russia

  • LLC "Zvezdnaya Clinic"

    RECRUITING

    Saint Petersburg, 196158, Russia

  • Llc "Diagnosis and Vaccines"

    WITHDRAWN

    Moscow, 129515, Russia

  • Llc "Medlight"

    RECRUITING

    Kazan', 420097, Russia

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

    RECRUITING

    Saransk, 430005, Russia

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

    NOT_YET_RECRUITING

    Omsk, 644099, Russia

  • Rostov State Medical University/Department of Childhood Diseases # 3

    RECRUITING

    Rostov-on-Don, 344022, Russia

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

    NOT_YET_RECRUITING

    Saint Petersburg, 194100, Russia

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

    RECRUITING

    Samara, 443079, Russia

  • Samara State Medical University/Department of Hospital Pediatrics

    WITHDRAWN

    Samara, 443099, Russia

  • Saratov City Children's Clinical Hospital

    WITHDRAWN

    Saratov, 410064, Russia

  • Specialized Clinical Infectious Diseases Hospital

    RECRUITING

    Krasnodar, 350015, Russia

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

    RECRUITING

    Yekaterinburg, 620028, Russia

  • Yaroslavl State Medical University/Department of Pediatrics, INPO

    RECRUITING

    Yaroslavl, 150000, Russia

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

    NOT_YET_RECRUITING

    Ryazan, 390026, Russia

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