Nigella Sativa Oil for Eczematous Otitis Externa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mometasone Furoate (MF), Nigella sativa oil.
- Who it may be relevant to
- Registry conditions: Eczema/Atopic Dermatitis, Otitis Externa. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Nigella Sativa Oil in Eczematous Otitis Externa: A Randomized Controlled Study
Overview
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.
Detailed description
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.
Interventions
- Drug Mometasone Furoate (MF)
Topical corticosteroid solution administered as ear drops (2 drops twice daily for 10 days). - Drug Nigella sativa oil
A fixed oil obtained from Nigella sativa seeds, administered as ear drops (2 drops twice daily for 10 days).
Primary outcome measures
- Change in objective inflammatory findings of the external ear from baseline to Day 10 [Time frame: Baseline to Day 10]
Secondary outcome measures (4)
- Change in itching score from baseline to Day 10 [Time frame: Baseline to Day 10]
- Change in pain score from baseline to Day 10 [Time frame: Baseline to Day 10]
- Change in discomfort score from baseline to Day 10 [Time frame: Baseline to Day 10]
- Change in otorrhea score from baseline to Day 10 [Time frame: Baseline to Day 10]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Bezmialem Vakif University — Istanbul
Identifiers
NCT: NCT07525505 · BVU-KBB-EKDE-01