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Recruiting Phase 3 NCT07171099

Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children

Trial Parameters

Condition Cough
Sponsor Materia Medica Holding
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 264
Sex ALL
Min Age 6 Months
Max Age 3 Years
Start Date 2025-10-03
Completion 2028-12-31
Interventions
RengalinPlacebo

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 Bron

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