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

Last updated: June 27, 2025
Sponsor: Liaquat University of Medical & Health Sciences
Overall Status: Completed

Phase

N/A

Condition

Common Cold

Allergy

Nasal Obstruction

Treatment

Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)

Saline Solution (0.9% NaCl)

Clinical Study ID

NCT06758804
116_22.11.2024_BACTORINOL_Siti
  • Ages 2-10
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children aged 2 to 10 years.

  • Clinical symptoms of dense mucosal rhinitis/purulent mucus.

  • Onset of symptoms ≤ 5 days before enrollment.

Exclusion

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 Design

Total Participants: 105
Treatment Group(s): 2
Primary Treatment: Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)
Phase:
Study Start date:
January 02, 2025
Estimated Completion Date:
June 15, 2025

Study 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.

Connect with a study center

  • Università degli Studi dell'Insubria

    Varese,
    Italy

    Site Not Available

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