NCT07198607

Pistacia Lentiscus Oil Nasal Drops for Preventing Recurrence of Chronic Rhinosinusitis

The Role of Pistacia Lentiscus Oil as a Preventive Tool for Chronic Rhinosinusitis Recurrence in Long-Term Therapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, placebo-controlled clinical trial evaluated the safety and efficacy of nasal drops containing Pistacia lentiscus oil in preventing recurrence of chronic rhinosinusitis. Adult patients with chronic rhinosinusitis were randomized 1:1 to receive either isotonic saline wash plus Pistacia lentiscus oil drops or isotonic saline wash plus placebo, for a total treatment duration of 12 months. The primary outcome was change in Sino-Nasal Outcome Test-22 (SNOT-22) scores, while secondary outcomes included ciliary motility, nasal secretion, biofilm presence, cytological changes, adverse events, and safety/tolerability.

Detailed description

Chronic rhinosinusitis (CRS) is a common and recurrent condition associated with significant morbidity and impaired quality of life. Standard treatment approaches often provide only partial or temporary relief, and recurrence rates remain high. Pistacia lentiscus oil has demonstrated anti-inflammatory and mucosal protective properties, supporting its potential role as a preventive intervention in CRS management. This monocenter, non-profit, randomized, placebo-controlled trial was designed to evaluate the long-term preventive effect of Pistacia lentiscus oil nasal drops on CRS recurrence. One hundred patients aged ≥18 years with diagnosed CRS were randomized in a 1:1 ratio to either the intervention group (isotonic saline wash plus Pistacia lentiscus oil drops, 5 drops per nostril twice daily for 30 days, followed by maintenance treatment for 15 days per month over 11 months) or the placebo group (isotonic saline wash plus placebo drops on the same schedule). The primary endpoint was the change in disease-specific quality of life, measured by the Sino-Nasal Outcome Test-22 (SNOT-22) from baseline to 12 months. Secondary endpoints included assessments of ciliary motility, nasal secretion, presence of biofilm, supranuclear striae, bacterial cells, variations in inflammatory cellularity (neutrophils, eosinophils, mast cells), safety, and tolerability. The study received ethical approval from the Italian Academy of Rhinology (Ref: IAR20221123).

Conditions

• Chronic Rhinosinusitis Without Nasal Polyps
• Chronic Rhinosinusitis (Diagnosis)

Interventions

Type	Name	Description
OTHER	Pistacia lentiscus Oil Nasal Drops (Bactorinol®)	Bactorinol® nasal drops (medical device containing ultra-fractioned and winterized Pistacia lentiscus oil). Participants will receive isotonic saline nasal wash plus 5 drops per nostril twice daily for 30 days, followed by 5 drops per nostril twice daily for 15 days per month for the subsequent 11 months.
OTHER	Placebo Nasal Drops (matched to Bactorinol®)	Placebo nasal drops identical in appearance and administration to Bactorinol®. Participants will receive isotonic saline nasal wash plus placebo drops, 5 drops per nostril twice daily for 30 days, followed by 5 drops per nostril twice daily for 15 days per month for the subsequent 11 months.

Timeline

• Start date: 2024-03-04
• Primary completion: 2025-06-18
• Completion: 2025-08-30
• First posted: 2025-09-30
• Last updated: 2026-02-25

Locations

1 site across 1 country: Italy