Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498843
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-27
Brief Title:
Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory InfectionsConditions
Sponsor:
YSLab
Organization:
YSLab
Study Overview
Official Title:
Clinical Evaluation of the Effectiveness of Nasal Pump Spray Medical Devices DM004 and DM020 Based on Diluted Seawater in the Treatment of Colds Rhinitis Sinusitis and Other Upper Respiratory InfectionsConditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 upper respiratory infectionsconditions for 7 days
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 discomfort chills rated as absent mild moderate or severe by the physicianinvestigator on Day 0 immediately after the first use on Day 3 and on Day 7
The clinical evaluation is also conducted by the ENT specialist using the CGI Clinical Global Impression - 7-point scale on Day 0 immediately after the first use on Day 3 and on Day 7 and by patients using the PGI Patient Global Impression - 7-point scale every day
Concomitant treatments number and timing of daily use and tolerance adverse effects will also be studied
The clinical evaluation is also conducted by the ENT specialist using the CGI Clinical Global Impression - 7-point scale on Day 0 immediately after the first use on Day 3 and on Day 7 and by patients using the PGI Patient Global Impression - 7-point scale every day
Concomitant treatments number and timing of daily use and tolerance adverse effects will also be studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None