Nigella sativa (black seed) oil versus mometasone ear drops for eczematous otitis externa
Efficacy of Nigella Sativa Oil in Eczematous Otitis Externa: A Randomized Controlled Study
This will test whether black seed (Nigella sativa) oil works as well as mometasone ear drops for adults with eczematous otitis externa.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bezmialem Vakif University Academic / other |
| Locations | 1 site (Istanbul, Fatih) |
| Trial ID | NCT07525505 on ClinicalTrials.gov |
What this trial studies
This randomized, single-blinded, controlled trial will assign adults with clinically diagnosed eczematous otitis externa to receive either topical Nigella sativa oil or mometasone furoate 0.1% ear drops twice daily for 10 days. Clinical signs (hyperemia, scaling) and patient-reported symptoms (itching, pain, discharge) will be recorded at baseline and after treatment, with objective photographic assessments by a blinded evaluator. The primary outcome is change in objective inflammatory findings; secondary outcomes include changes in symptom scores. The design compares the efficacy and safety of a natural oil against a topical corticosteroid in a head-to-head format.
Who should consider this trial
Good fit: Adults aged 18 and older with a clinical diagnosis of eczematous otitis externa who have at least one ear symptom and can provide informed consent.
Not a fit: Patients with acute bacterial otitis externa requiring antibiotics, known allergy to either treatment, recent corticosteroid or ear medication use, prior ear surgery, severe comorbidity, or who are pregnant or breastfeeding may not benefit or be eligible.
Why it matters
Potential benefit: If effective, Nigella sativa oil could provide a steroid-sparing, natural topical option with anti-inflammatory and antimicrobial effects for patients with eczematous otitis externa.
How similar studies have performed: Preclinical data and small dermatologic studies suggest anti-inflammatory and antimicrobial effects of Nigella sativa, but randomized comparisons with topical corticosteroids for eczematous otitis externa are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Istanbul, Fatih
- Bezmialem Vakif University — Istanbul, Fatih, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Nazan Degirmenci, MD,Assoc. Prof.
- Email: nzndegirmenci@hotmail.com
- Phone: +90(212) 523 22 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.