Nigella Sativa Oil for Eczematous Otitis Externa

Eczematous otitis externa is a chronic inflammatory condition of the external auditory canal characterized by pruritus, erythema, scaling, and discomfort. Although topical corticosteroids are commonly used as first-line therapy, their prolonged use may be associated with adverse effects, prompting interest in alternative treatment options.

Nigella sativa oil, a natural product with documented anti-inflammatory, antioxidant, and antimicrobial properties, may represent a potential therapeutic alternative in inflammatory ear conditions.

This study will be conducted as a prospective, randomized, single-blinded, controlled clinical trial. Adult patients with clinically diagnosed eczematous otitis externa will be randomly assigned in a 1:1 ratio to receive either Nigella sativa oil or mometasone furoate 0.1% ear drops, administered twice daily for 10 days.

Clinical assessments will be performed at baseline and at the end of treatment. Patient-reported symptoms, including itching, discomfort, otorrhea, and pain, will be evaluated using a numeric rating scale. Objective inflammatory findings, including hyperemia and squamation of the external auditory canal and external ear, will be assessed using standardized photographic documentation by a blinded evaluator.

The primary outcome will be the change in objective inflammatory findings from baseline to the end of treatment. Secondary outcomes will include changes in patient-reported symptom scores.

The results of this study are expected to provide evidence regarding the efficacy and safety of Nigella sativa oil as a potential alternative to topical corticosteroid therapy in the management of eczematous otitis externa.

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