Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
ConditionCough
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-3
SponsorMateria Medica Holding
About this trial
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
Qualifiers
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.
Disqualifiers
Suspected bacterial infection of any localization, including pneumonia, sinusitis, otitis media.
Allergic rhinitis.
Bronchial obstruction syndrome.
Acute obstructive laryngitis [croup] and epiglottitis.
Trial design
Treatments tested in this trial
- Rengalin
- Placebo
Treatment groups
264 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov