NCT07171099 Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
| NCT ID | NCT07171099 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Materia Medica Holding |
| Condition | Cough |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 264 participants in total. It began in 2025-10-03 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07171099 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 3 Years, studying Cough. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07171099 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 264 participants.
Is NCT07171099 currently recruiting?
Yes, NCT07171099 is actively recruiting participants. Contact the research team at PutilovskiyMA@materiamedica.ru for enrollment information.
Where is the NCT07171099 trial being conducted?
This trial is being conducted at Gatchina, Russia, Kazan', Russia, Krasnodar, Russia, Moscow, Russia and 11 additional locations.
Who is sponsoring the NCT07171099 clinical trial?
NCT07171099 is sponsored by Materia Medica Holding. The trial plans to enroll 264 participants.