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NOT YET RECRUITING
NCT07266688
NA

Evaluation of Bactorinol® Nasal Spray in Adult Patients With Vasomotor Rhinitis

Sponsor: Liaquat University of Medical & Health Sciences

View on ClinicalTrials.gov

Summary

This study aims to evaluate the effectiveness and safety of Bactorinol® nasal spray, a medical device containing winterized Pistacia lentiscus oil, in adults with vasomotor rhinitis. Vasomotor rhinitis is a chronic condition characterized by nasal congestion, rhinorrhea, and impaired nasal airflow. In this multicenter, prospective, randomized, controlled clinical trial, 100 adult participants will be assigned in a 1:1 ratio to receive either Bactorinol® nasal spray or isotonic saline solution for 20 consecutive days. The primary objective is to determine whether Bactorinol® improves nasal airflow, measured by Peak Nasal Inspiratory Flow (PNIF). Secondary objectives include evaluating changes in symptoms and quality of life using the SNOT-22 questionnaire, assessing nasal cytology, and monitoring treatment compliance and adverse events. The results of this study may help identify a non-pharmacological, natural-extract-based treatment option for patients with vasomotor rhinitis.

Official title: Evaluation of the Efficacy and Safety of Treatment With a Medical Device Containing Pistacia Lentiscus in Patients With Vasomotor Rhinitis: A Multicenter, Prospective, Randomized, Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-12-01

Completion Date

2026-05-29

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

DEVICE

Bactorinol® Nasal Spray

Bactorinol® nasal spray containing winterized Pistacia lentiscus oil. Administered as 3 puffs per nostril, three times daily for 20 consecutive days.

OTHER

Isotonic Saline Solution

Isotonic saline nasal spray administered as 3 sprays per nostril, three times daily for 20 consecutive days.

Locations (1)

Università di Urbino Carlo Bo

Urbino, Pesaro E Urbino, Italy