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

Not Applicable

Recruiting

• Conditions: Rhinitis Acute

• Registration Number: NCT06758804
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief 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.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study Start: 2025-01-02
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Purulent Rhinitis Symptoms	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 Outcome Measures

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

Trial Locations

Locations (1)

Università degli Studi dell'Insubria; 🇮🇹 Varese, Italy