Status:
NOT_YET_RECRUITING
Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory Infections/Conditions
Lead Sponsor:
YSLab
Conditions:
Rhinitis
Sinusitis
Eligibility:
All Genders
3+ years
Phase:
NA
Brief 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 u...
Detailed Description
The main endpoint is a symptom score evaluation. Severity is evaluated using the Jackson scale, which includes 8 symptoms (nasal discharge, nasal congestion, sneezing, sore throat, cough, headache, di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT06498843
Start Date
January 1 2025
End Date
June 1 2025
Last Update
August 2 2024
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