Nigella Sativa Oil for Eczematous Otitis Externa
Recruiting · NCT07525505 · Interventional (participants receive a specific treatment) · Lead sponsor: Bezmialem Vakif University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Eczematous otitis externa is a common inflammatory condition of the external auditory canal characterized by itching, discomfort, discharge, and pain. Topical corticosteroids are widely used for treatment; however, alternative therapies with fewer side effects are of increasing interest. This study aims to compare the efficacy of Nigella sativa (black seed) oil and mometasone furoate ear drops in the treatment of eczematous otitis externa. Nigella sativa is a natural product with known anti-inflammatory and antimicrobial properties. In this randomized, controlled clinical trial, adult patients with eczematous otitis externa will be assigned to receive either Nigella sativa oil or mometasone furoate ear drops for 10 days. Clinical symptoms and inflammatory findings will be evaluated at baseline and after treatment. The objective of this study is to determine whether Nigella sativa oil is an effective and safe alternative to topical corticosteroid therapy.
Who can take part
Inclusion criteria
- Adult patients aged 18 years and older
- Clinical diagnosis of eczematous otitis externa confirmed by otoscopic examination
- Presence of at least one symptom related to the affected ear (itching, discomfort, otorrhea, or pain)
- Willingness to participate and ability to provide written informed consent
Exclusion criteria
- Known hypersensitivity or allergic reaction to Nigella sativa oil or mometasone furoate
- Use of topical or systemic corticosteroids or other ear medications within a defined period prior to enrollment
- Presence of acute otitis externa of infectious origin requiring antibiotic treatment
- History of ear surgery or structural abnormalities of the external auditory canal
- Severe systemic disease or condition that may interfere with study participation
- Pregnant or breastfeeding women
Where it is running
1 location listed.
- Bezmialem Vakif University - Istanbul, Fatih, Turkey (Türkiye)