Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07525505

Nigella Sativa Oil for Eczematous Otitis Externa

Led by Bezmialem Vakif University · Updated on 2026-04-21

85

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Nigella Sativa Oil for Eczematous Otitis Externa

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye), 34093

Actively Recruiting

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Research Team

N

Nazan Degirmenci, MD,Assoc. Prof.

CONTACT

M

muhammed said ekinci, resident MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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