Status:
NOT_YET_RECRUITING
Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
Lead Sponsor:
Materia Medica Holding
Conditions:
Cough
Eligibility:
All Genders
6-3 years
Phase:
PHASE3
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 child...
Detailed Description
The design is a multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial evaluating the efficacy and safety of the study therapy. The trial will enroll children of eit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Presence of the following diseases at the time of inclusion in the clinical trial:
- 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.
- 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.
- Taking medications listed in the section "Prohibited Concomitant Therapy" within 4 weeks prior to inclusion in the study.
- 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.
- Participation in other clinical trials within 3 months prior to inclusion in this trial.
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT07171099
Start Date
October 1 2025
End Date
December 31 2028
Last Update
September 15 2025
Active Locations (14)
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1
Gatchina Clinical Interdistrict Hospital
Gatchina, Russia, 188300
2
Llc "Medlight"
Kazan', Russia, 420097
3
Specialized Clinical Infectious Diseases Hospital
Krasnodar, Russia, 350015
4
First Moscow State Medical University named after I.M. Sechenov
Moscow, Russia, 119991