An interventional study of Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®) and Saline Solution (0.9% NaCl) in Rhinitis Acute, sponsored by Liaquat University of Medical & Health Sciences. Completed at 1 site in Italy. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Device: Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)
Device: Saline Solution (0.9% NaCl)
Participants will receive winterized Pistacia lentiscus oil nasal drops (Bactorinol®), administered as 3 drops per nostril, three times daily for six consecutive days.
Participants will receive a saline solution (0.9% NaCl) administered as 3 drops per nostril, three times daily for six consecutive days.
Change in Purulent Rhinitis Symptoms
Evaluate the change in symptoms of purulent rhinitis, such as nasal congestion and mucosal discharge, in the experimental group compared to the control group.
Time frame: 6 days
Change in Antibiotic Use
Measure the percentage of participants experiencing a change in antibiotic therapy requirements in the experimental group compared to the control group.
Time frame: 6 days
Change in nasal obstruction
Change in the nasal obstruction measured via a 10-point Visual Analog Scale.
Time frame: 6 days
Incidence of Treatment-Emergent Adverse Events
Record the number and type of treatment-emergent adverse events (TEAEs) related to the use of the intervention.
Time frame: 6 days
Plan to share: No
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Liaquat University of Medical & Health Sciences