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| Name | Class |
|---|---|
| Università degli Studi dell'Insubria | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Winterized Pistacia Lentiscus Oil Drops | Experimental |
| |
| Saline Placebo Drops | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 days |
| Change in nasal obstruction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università degli Studi dell'Insubria | Varese | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16861253 | Background | Arroll B, Kenealy T. Are antibiotics effective for acute purulent rhinitis? Systematic review and meta-analysis of placebo controlled randomised trials. BMJ. 2006 Aug 5;333(7562):279. doi: 10.1136/bmj.38891.681215.AE. Epub 2006 Jul 21. | |
| 29114245 | Background | Orru G, Demontis C, Mameli A, Tuveri E, Coni P, Pichiri G, Coghe F, Rosa A, Rossi P, D'hallewin G. The Selective Interaction of Pistacia lentiscus Oil vs. Human Streptococci, an Old Functional Food Revisited with New Tools. Front Microbiol. 2017 Oct 24;8:2067. doi: 10.3389/fmicb.2017.02067. eCollection 2017. |
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| 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. |
|
Change in the nasal obstruction measured via a 10-point Visual Analog Scale.
| 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. | 6 days |
| 34220777 | Background | Di Pierro F, Sagheddu V, Galletti S, Forti M, Elli M, Bertuccioli A, Gaeta S. Antibacterial Activity of a Fractionated Pistacia lentiscus Oil Against Pharyngeal and Ear Pathogens, Alone or in Combination With Antibiotics. Front Microbiol. 2021 Jun 17;12:686942. doi: 10.3389/fmicb.2021.686942. eCollection 2021. |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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