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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06498843). StuddyBuddy aggregates publicly available trial information.