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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-02

Study Completion Date

2025-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rhinitis Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Winterized Pistacia Lentiscus Oil Drops

Group Type EXPERIMENTAL

Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)

Intervention Type DEVICE

Participants will receive winterized Pistacia lentiscus oil nasal drops (Bactorinol®), administered as 3 drops per nostril, three times daily for six consecutive days.

Saline Placebo Drops

Group Type PLACEBO_COMPARATOR

Saline Solution (0.9% NaCl)

Intervention Type DEVICE

Participants will receive a saline solution (0.9% NaCl) administered as 3 drops per nostril, three times daily for six consecutive days.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No