Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children (NCT07171099) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
Russia264 participantsStarted 2025-10-03
Plain-language 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.
Who can participate
Age range6 Months – 3 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.