Rhinitis Acute
Conditions
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.
Interventions
DEVICEWinterized 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.
Participants will receive a saline solution (0.9% NaCl) administered as 3 drops per nostril, three times daily for six consecutive days.
Sponsors
Università degli Studi dell'Insubria
Liaquat University of Medical & Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed