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Completed

NCT Number: NCT06758804

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

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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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università degli Studi dell'Insubria

Varese, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)

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 Solution (0.9% NaCl)

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Change in nasal obstruction

    Time frame: 6 days

    Change in the nasal obstruction measured via a 10-point Visual Analog Scale.

  3. 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.

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • Università degli Studi dell'Insubria

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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