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Completed
NCT06498843
Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory Infections/Conditions
Conditions: Rhinitis, Sinusitis, Upper Respiratory Infections, Colds
Sex: All
Ages: 3 Months – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 89
Sponsor: YSLab
Location: Eurofins Dermscan Poland Gdansk
Summary
The goal of this interventional clinical trial is to test the safety and efficacy of two medical devices in subjects aged from 3 months old for the treatment of colds, rhinitis, sinusitis, and other upper respiratory infections/conditions for 7 days.
Eligibility Criteria
Inclusion Criteria:
* Autonomous adult, or minor with the consent of their legal representative
* Adults and children from 3 months old
* Ability of the patient (for adults) or their legal representative (for children) to follow the instructions for product use
* Having signed a free and informed consent to participate in the study expressed by the patient (for adults) or by their legal representative (for children) after being informed by the doctor.
* Person with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis…) with symptoms of nasal congestion and nasal discharge of moderate to severe intensity (Jackson derived score (nasal congestion + nasal discharge) ≥ 4 on Day 0).
* Persons with symptoms that started no more than 48 hours before the first visit
Exclusion Criteria:
* Person not showing cold symptoms, particularly no nasal congestion (chronic dry rhinitis, or Jackson derived score (nasal congestion + nasal discharge) \< 4 on Day 0).
* Person undergoing treatment with a cortisone derivative, mucolytic, or medication containing pseudoephedrine or a similar product acting on nasal congestion or having used such a product within the 3 days preceding inclusion.
* Person having used a nasal wash product within the 3 days preceding inclusion.
* Person whose ability to use the product daily and complete the daily follow-up diary is in doubt.
* Person refusing to sign the informed consent form prior to the study.
* Person participating or having participated in any other clinical study within the 30 days preceding the study.
* Person participating in any other clinical study.
Source: ClinicalTrials.gov (NCT06498843). StuddyBuddy aggregates publicly available trial information.