Nigella Sativa Oil for Eczematous Otitis Externa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBezmialem Vakif University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mometasone Furoate (MF)
DrugTopical corticosteroid solution administered as ear drops (2 drops twice daily for 10 days).
Nigella sativa oil
DrugA fixed oil obtained from Nigella sativa seeds, administered as ear drops (2 drops twice daily for 10 days).
Treatment groups
85 Participants
are divided into 2 treatment groupsGroup A: nigella sativaExperimental treatment 1 intervention
Group B: mometasone furoateActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in objective inflammatory findings of the external ear from 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.
Time frame
Baseline to Day 10Secondary outcomes
1
Change in itching score from baseline to Day 10
Itching severity will be assessed using a Numeric Rating Scale (0-10). Changes from baseline to Day 10 will be evaluated.
Time frame
Baseline to Day 102
Change in pain score from baseline to Day 10
Pain severity will be assessed using a Numeric Rating Scale (0-10). Changes from baseline to Day 10 will be evaluated.
Time frame
Baseline to Day 103
Change in discomfort score from baseline to Day 10
Discomfort will be assessed using a Numeric Rating Scale (0-10). Changes from baseline to Day 10 will be evaluated.
Time frame
Baseline to Day 104
Change in otorrhea score from baseline to Day 10
Otorrhea severity will be assessed using a Numeric Rating Scale (0-10). Changes from baseline to Day 10 will be evaluated.
Time frame
Baseline to Day 10Sponsors and contacts
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Source ClinicalTrials.gov