RecruitingNot ApplicableNCT07525505

Nigella Sativa Oil for Eczematous Otitis Externa

Efficacy of Nigella Sativa Oil in Eczematous Otitis Externa: A Randomized Controlled Study


Sponsor

Bezmialem Vakif University

Enrollment

85 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

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Interventions

DRUGMometasone Furoate (MF)

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

DRUGNigella sativa oil

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


Locations(1)

Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye)

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NCT07525505


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