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

Liaquat University of Medical & Health Sciences

Status: Completed

Conditions: Rhinitis Acute

Treatments: Device: Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®); Device: Saline Solution (0.9% NaCl)

Study type: Interventional

Funder types: Other

Identifiers

NCT06758804

116_22.11.2024_BACTORINOL_Siti

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups, including a placebo group

Winterized Pistacia Lentiscus Oil Drops

Experimental group

Treatment:

Device: Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)

Saline Placebo Drops

Placebo Comparator group

Treatment:

Device: Saline Solution (0.9% NaCl)