Chronic Rhinosinusitis Without Nasal PolypsNCT07198607
Pistacia Lentiscus Oil Nasal Drops for Preventing Recurrence of Chronic Rhinosinusitis
An observational study of Chronic Rhinosinusitis Without Nasal Polyps and Chronic Rhinosinusitis (Diagnosis), run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial summary
This retrospective, observational, case-control clinical study evaluated the safety and efficacy of nasal drops containing Pistacia lentiscus oil in preventing recurrence of chronic rhinosinusitis during long-term therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis Without Nasal Polyps, Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Pistacia lentiscus Oil Nasal Drops (Bactorinol®) and Isotonic Saline Nasal Wash
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Apr 2023to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged ≥18 years with diagnosed chronic rhinosinusitis (CRS) who underwent long-term treatment with isotonic saline nasal wash plus Pistacia lentiscus oil nasal drops or isotonic saline nasal wash alone in a real-world clinical setting were retrospectively evaluated.
Who may be able to join
- Age ≥18 years
- Clinical diagnosis of chronic rhinosinusitis
- Nasal polypoid score ≤1
- ≥4 episodes of recurrence per year
- SNOT-22 score ≥10 Willingness and ability to provide written informed consent
Who cannot join
- Nasal polypoid score >2
- <4 episodes of recurrence per year
- SNOT-22 score <10
- Known immune disorders
- Neoplastic disorders
- Neurological disorders
Show all 9Show fewer
- Psychiatric disorders
- Inability to undergo treatment
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Pistacia Lentiscus Oil in the Prevention of Chronic Rhinosinusitis Recurrence During Long-Term Therapy: A Retrospective Observational Case-Control Study
This retrospective, observational, case-control clinical study evaluated the safety and efficacy of nasal drops containing Pistacia lentiscus oil in preventing recurrence of chronic rhinosinusitis during long-term therapy. Adult patients with chronic rhinosinusitis who received isotonic saline wash plus Pistacia lentiscus oil drops were retrospectively compared with patients who received isotonic saline wash alone, with 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.
Read the 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 tool in CRS management.
This monocenter, non-profit, retrospective observational case-control clinical study was conducted 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 retrospectively evaluated and compared between patients receiving 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) and patients receiving isotonic saline wash alone 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.
- Being tested
- Pistacia lentiscus Oil Nasal Drops (Bactorinol®), Isotonic Saline Nasal Wash
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pistacia lentiscus Oil Nasal Drops (Bactorinol®)Other
Also called Winterized Pistacia lentiscus oil; Bactorinol®
Bactorinol® nasal drops (medical device containing ultra-fractioned and winterized Pistacia lentiscus oil). Participants received 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.
Isotonic Saline Nasal WashOther
Participants received isotonic saline nasal wash alone according to the same administration schedule used in the comparison group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Pistacia lentiscus Oil Nasal Drops | Participants received isotonic saline nasal wash plus Pistacia lentiscus oil nasal drops. Dosage: 5 drops per nostril twice daily for 30 days, followed by maintenance therapy of 5 drops per nostril twice daily for 15 days each month over the subsequent 11 months. Receives: Other: Pistacia lentiscus Oil Nasal Drops (Bactorinol®) | |
| Saline Solution Control | Participants received isotonic saline nasal wash alone on the same administration schedule over the study period. Receives: Other: Isotonic Saline Nasal Wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sino-Nasal Outcome Test-22 (SNOT-22) score
The SNOT-22 questionnaire measures disease-specific quality of life in chronic rhinosinusitis patients. Scores range from 0 (no symptoms) to 110 (worst symptoms).
Measured: Baseline, 1 month, and 1 year
Secondary outcomes (9)
Ciliary motility
Assessment of ciliary beat frequency and duration using phase contrast optical microscopy; considered normal if beating lasts >10 minutes.
Measured: Baseline, 1 month, and 1 year
Presence of Nasal Secretion
Presence or absence of nasal secretion, assessed by anterior rhinoscopy.
Measured: Baseline, 1 month, and 1 year
Characteristics of Nasal Secretion
Nasal secretion characteristics (clear, mucopurulent, or purulent) will be graded by anterior rhinoscopy using standardized clinical evaluation.
Measured: Baseline, 1 month, and 1 year
Presence of biofilm
Cytological evaluation of mucosal samples stained for biofilm, identified by cyan-colored areas.
Measured: Baseline, 1 month, and 1 year
Presence of supranuclear striae
Microscopic evaluation of nasal mucosa samples for supranuclear striae.
Measured: Baseline, 1 month, and 1 year
Presence of bacterial cells
Cytological evaluation of mucosal samples for bacterial cells.
Measured: Baseline, 1 month, and 1 year
Cellularity variation
Quantitative cytology of neutrophils, eosinophils, and mast cells from nasal mucosa samples.
Measured: Baseline, 1 month, and 1 year
Number of Participants With Treatment-Related Adverse Events
Safety will be assessed by recording all adverse events (local and systemic) related to nasal drop use, as evaluated by the investigator.
Measured: Throughout study period (up to1 year)
Local Tolerability of Nasal Drops
Local tolerability will be assessed by anterior rhinoscopy for signs of nasal irritation (redness, swelling, mucosal damage) and patient-reported nasal discomfort using a Visual Analogue Scale (0-10).
Measured: Baseline, 1 month, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start4 Apr 2023
- Primary completion3 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis Without Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198607
- Sponsor's protocol ID
- 116_22novembre2024_BACTORINOL
- Status last verified
- May 2026
- First submitted
- 15 Sep 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pistacia Lentiscus Oil in the Prevention of Chronic Rhinosinusitis Recurrence During Long-Term Therapy: A Retrospective Observational Case-Control Study
- ClinicalTrials.gov ID
- NCT07198607
- Acronym / sponsor ID
- 116_22novembre2024_BACTORINOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective, observational, case-control clinical study evaluated the safety and efficacy of nasal drops containing Pistacia lentiscus oil in preventing recurrence of chronic rhinosinusitis during long-term therapy. Adult patients with chronic rhinosinusitis who received isotonic saline wash plus Pistacia lentiscus oil drops were retrospectively compared with patients who received isotonic saline wash alone, with 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 tool in CRS management.
This monocenter, non-profit, retrospective observational case-control clinical study was conducted 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 retrospectively evaluated and compared between patients receiving 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) and patients receiving isotonic saline wash alone 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Pistacia lentiscus Oil Nasal Drops | – | Other: Pistacia lentiscus Oil Nasal Drops (Bactorinol®)Participants received isotonic saline nasal wash plus Pistacia lentiscus oil nasal drops. Dosage: 5 drops per nostril twice daily for 30 days, followed by maintenance therapy of 5 drops per nostril twice daily for 15 days each month over the subsequent 11 months. |
| Saline Solution Control | – | Other: Isotonic Saline Nasal WashParticipants received isotonic saline nasal wash alone on the same administration schedule over the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged ≥18 years with diagnosed chronic rhinosinusitis (CRS) who underwent long-term treatment with isotonic saline nasal wash plus Pistacia lentiscus oil nasal drops or isotonic saline nasal wash alone in a real-world clinical setting were retrospectively evaluated.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Clinical diagnosis of chronic rhinosinusitis
- Nasal polypoid score ≤1
- ≥4 episodes of recurrence per year
- SNOT-22 score ≥10 Willingness and ability to provide written informed consent
Key exclusion criteria (9 listed)
- Nasal polypoid score >2
- <4 episodes of recurrence per year
- SNOT-22 score <10
- Known immune disorders
- Neoplastic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pistacia lentiscus Oil Nasal Drops (Bactorinol®)Also: Winterized Pistacia lentiscus oil; Bactorinol®Bactorinol® nasal drops (medical device containing ultra-fractioned and winterized Pistacia lentiscus oil). Participants received 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 | Experimental: Pistacia lentiscus Oil Nasal Drops |
| Isotonic Saline Nasal WashParticipants received isotonic saline nasal wash alone according to the same administration schedule used in the comparison group. | Other | Saline Solution Control |
Primary outcome
Change in Sino-Nasal Outcome Test-22 (SNOT-22) score
Time frame: Baseline, 1 month, and 1 year
The SNOT-22 questionnaire measures disease-specific quality of life in chronic rhinosinusitis patients. Scores range from 0 (no symptoms) to 110 (worst symptoms).
9 secondary outcomes
Ciliary motility
Time frame: Baseline, 1 month, and 1 year
Presence of Nasal Secretion
Time frame: Baseline, 1 month, and 1 year
Characteristics of Nasal Secretion
Time frame: Baseline, 1 month, and 1 year
Presence of biofilm
Time frame: Baseline, 1 month, and 1 year
Presence of supranuclear striae
Time frame: Baseline, 1 month, and 1 year
Presence of bacterial cells
Time frame: Baseline, 1 month, and 1 year
Cellularity variation
Time frame: Baseline, 1 month, and 1 year
Number of Participants With Treatment-Related Adverse Events
Time frame: Throughout study period (up to1 year)
Local Tolerability of Nasal Drops
Time frame: Baseline, 1 month, and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis Without Nasal Polyps and Chronic Rhinosinusitis (Diagnosis), run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sino-Nasal Outcome Test-22 (SNOT-22) score (time frame: Baseline, 1 month, and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.