Nigella sativa (black seed) oil versus mometasone ear drops for eczematous otitis externa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.