Nigella Sativa Oil for Eczematous Otitis Externa

Condition(s) studied

Investigational drug(s) / intervention(s)

Mometasone Furoate (MF): Topical corticosteroid solution administered as ear drops (2 drops twice daily for 10 days).

Nigella sativa oil: A fixed oil obtained from Nigella sativa seeds, administered as ear drops (2 drops twice daily for 10 days).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in objective inflammatory findings of the external ear from baseline to Day 10 — Baseline to Day 10
  Objective inflammatory findings, including external auditory canal hyperemia, edema, and desquamation, will be assessed using a standardized clinical inflammation scoring system (range: 0-3 for each parameter; total score range: 0-9). Higher scores indicate more severe inflammation. Changes in total score from baseline to Day 10 will be analyzed.

Trial sites (1)

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