Efficacy of Winterized Pistacia Lentiscus Oil in Reducing Purulent Bacterial Overinfection of Pediatric Rhinitis

June 27, 2025 updated by: Dr. Amjad Khan, Liaquat University of Medical & Health Sciences

Evaluation of the Efficacy of Winterized Pistacia Lentiscus Oil in Reducing Purulent Bacterial Overinfection of Pediatric Rhinitis: A Multicenter Randomized Controlled Trial

This study aims to evaluate the efficacy and safety of a medical device containing winterized Pistacia lentiscus oil in reducing symptoms of purulent bacterial overinfection in pediatric rhinitis and the need for antibiotic therapy. The randomized controlled trial will compare the treatment group receiving nasal drops with a control group using saline solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, randomized controlled trial to assess the therapeutic potential of winterized Pistacia lentiscus oil (WLO) in pediatric patients aged 2 to 10 years with purulent rhinitis. The study will investigate the reduction of rhinitis symptoms, the need for antibiotics, and secondary outcomes including nasal decongestant activity and treatment safety.

Participants will be randomized into two groups: the intervention group will receive 3 drops of WLO per nostril, three times daily for six days, while the control group will use 0.9% saline solution under the same regimen. Clinical evaluations will be conducted by medical staff and parents over six days to record symptom improvement, antibiotic use, and adverse events. The results will contribute to understanding the potential of WLO as a non-antibiotic treatment option for purulent bacterial overinfection in pediatric rhinitis.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Varese, Italy
        • Università degli Studi dell'Insubria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 2 to 10 years.
  • Clinical symptoms of dense mucosal rhinitis/purulent mucus.
  • Onset of symptoms ≤ 5 days before enrollment.

Exclusion Criteria:

  • Onset of symptoms > 5 days before enrollment.
  • Presence of neurological, malformative, or immunological pathology.
  • Suspected or confirmed allergy to the active substance.
  • Use of antibiotics within 48 hours prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Winterized Pistacia Lentiscus Oil Drops
Device: Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)
Participants will receive winterized Pistacia lentiscus oil nasal drops (Bactorinol®), administered as 3 drops per nostril, three times daily for six consecutive days.
Placebo Comparator: Saline Placebo Drops
Device: Saline Solution (0.9% NaCl)
Participants will receive a saline solution (0.9% NaCl) administered as 3 drops per nostril, three times daily for six consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Purulent Rhinitis Symptoms
Time Frame: 6 days
Evaluate the change in symptoms of purulent rhinitis, such as nasal congestion and mucosal discharge, in the experimental group compared to the control group.
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Antibiotic Use
Time Frame: 6 days
Measure the percentage of participants experiencing a change in antibiotic therapy requirements in the experimental group compared to the control group.
6 days
Change in nasal obstruction
Time Frame: 6 days
Change in the nasal obstruction measured via a 10-point Visual Analog Scale.
6 days
Incidence of Treatment-Emergent Adverse Events
Time Frame: 6 days
Record the number and type of treatment-emergent adverse events (TEAEs) related to the use of the intervention.
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat University of Medical & Health Sciences

Collaborators

Università degli Studi dell'Insubria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Actual)

June 3, 2025

Study Completion (Actual)

June 15, 2025

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

January 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116_22.11.2024_BACTORINOL_Siti

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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