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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Rengalin
DrugSolution for oral administration
Placebo
DrugSolution for oral administration
Treatment groups
264 Participants
are divided into 2 treatment groupsGroup A: RengalinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The percentage of patients responded to treatment
The percentage of patients responded to treatment (reduction in the total (day and night) cough severity score to 3 points or less after 3 days of treatment - isolated cough episodes or complete absence of cough during the day) after 3 days.
Time frame
On baseline and 3 daySecondary outcomes
1
Change in the total CSS
Change in the total Cough Severity Score (daytime and nighttime) after 7 days of treatment compared to baseline. The minimum value - 0 (no cough) and maximum value - 10 (severe cough).
Time frame
On baseline and 7 dayOther outcomes
1
Percentage of patients without daytime cough
Percentage of patients with no daytime cough acording to Cough Severity Score (SCC) after 7 days of treatment. The minimum value - 0 (no cough) and maximum value - 5 (severe cough).
Time frame
On baseline and 7 day2
Percentage of patients with a decrease in daytime cough
Percentage of patients with a decrease in daytime cough severity ≤ 1 point on the Cough Severity Score (SCC) after 7 days of treatment. The minimum value - 0 (no cough) and maximum value - 5 (severe cough).
Time frame
On baseline and 7 day3
Percentage of patients without night cough
Percentage of patients with no night cough (0 points according to the Cough Severity Score (SCC)) after 7 days of treatment. The minimum value - 0 (no cough) and maximum value - 5 (severe cough).
Time frame
On baseline and 7 day4
Percentage of patients with a reduction in nighttime cough
Percentage of patients with a reduction in nighttime cough severity ≤ 1 point on the Cough Severity Score (SCC) after 7 days of treatment. The minimum value - 0 (no cough) and maximum value - 5 (severe cough).
Time frame
On baseline and 7 daySponsors and contacts
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Source ClinicalTrials.gov