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Rengalin liquid for dry cough in children aged 6 months to 3 years

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

Phase 3 Interventional Materia Medica Holding · NCT07171099

This will test whether Rengalin liquid reduces dry cough in children 6 months to 3 years old with acute viral upper respiratory infections.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment264 (estimated)
Ages6 Months to 3 Years
SexAll
SponsorMateria Medica Holding Industry-sponsored
Locations30 sites (Gatchina and 29 other locations)
Trial IDNCT07171099 on ClinicalTrials.gov

What this trial studies

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group phase 3 trial of Rengalin in a liquid form given orally as 5 ml three times daily for 7 days. The trial enrolls outpatients aged 6 months to under 3 years who have a dry (non-productive) cough of 24–72 hours' duration and a total cough severity score of 6 or more. At baseline parents complete the cough severity score, vital signs and physical exam are recorded, and at least 50% of participants will have basic blood and urine tests; safety and symptom outcomes are compared between Rengalin and placebo. The investigators will monitor cough severity and adverse events over the treatment period to determine efficacy and tolerability.

Who should consider this trial

Good fit: Ideal candidates are outpatients aged over 6 months and under 3 years with clinically diagnosed acute viral upper respiratory infection, a dry cough present 24–72 hours, and a total cough severity score of 6 or more, whose parent or guardian can attend one of the study sites and provide consent.

Not a fit: Children with productive cough, lower respiratory tract inflammation, chronic ENT conditions listed in the exclusions, gastroesophageal reflux, or those outside the specified age or cough-duration windows are unlikely to benefit from this intervention in this trial.

Why it matters

Potential benefit: If successful, Rengalin could shorten the duration or reduce the severity of dry cough in very young children, offering a tolerated symptomatic treatment option.

How similar studies have performed: Some smaller or non-randomized reports and post-marketing experience from the manufacturer’s region have suggested symptomatic benefit from Rengalin, but randomized placebo-controlled phase 3 evidence in this pediatric age group is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Gatchina and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CoughUpper respiratory infectionChildren from 6 months to 3 years
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.