Actively Recruiting

Age: 12Years +
All Genders
NCT06580210

Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction

Led by Laboratoires Gilbert · Updated on 2025-11-21

114

Participants Needed

3

Research Sites

84 weeks

Total Duration

On this page

Sponsors

L

Laboratoires Gilbert

Lead Sponsor

E

EVAMED

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.

CONDITIONS

Official Title

Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 12 years or older
  • Patient with acute rhinitis and nasal obstruction during infectious episodes like rhynopharyngitis, rhinosinusitis, or non-infectious episodes such as allergic rhinitis
  • Informed adult patient who has given written consent or informed minor patient with assent and guardian consent before any study procedure
  • Patient able to complete study questionnaires
  • Patient affiliated to a social security scheme
Not Eligible

You will not qualify if you...

  • Patient who does not want to participate in the clinical investigation
  • Hypersensitivity to seawater or allergies to any spray ingredients
  • Child with a history of febrile convulsions
  • Diseases causing respiratory insufficiency
  • Nasal deformity or nasal polyps causing chronic nasal obstruction
  • Current use of local or systemic vasoconstrictors, corticosteroids, antihistamines, NSAIDs, antibiotics, or local antiseptics
  • Use of other nasal sprays, essential oils for nasal use, nasal creams or gels
  • Patient under guardianship, curatorship, or legal protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Pharmacie du Pont Saint Jean

Bayeux, France, 14400

Not Yet Recruiting

2

Pharmacie de la Guérinière

Caen, France, 14000

Actively Recruiting

3

Pharmacie de la Force

La Force, France, 24130

Not Yet Recruiting

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Research Team

L

Léa RADDAY

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction | DecenTrialz