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Evaluation of Bactorinol® Nasal Spray in Adult Patients With Vasomotor Rhinitis
Sponsor: Liaquat University of Medical & Health Sciences
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
Conditions
Interventions
Bactorinol® Nasal Spray
Bactorinol® nasal spray containing winterized Pistacia lentiscus oil. Administered as 3 puffs per nostril, three times daily for 20 consecutive days.
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