Nigella Sativa Oil for Eczematous Otitis Externa

NCT07525505 | Recruiting

• 1 other identifier: BVU-KBB-EKDE-01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eczema/Atopic Dermatitis; Otitis Externa

Keywords

Eczematous Otitis Externa; External Ear Dermatitis; Nigella sativa oil

Outcome Measures

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.

  Baseline to Day 10

Secondary Outcomes (4)

• Change in itching score from baseline to Day 10

  Baseline to Day 10

• Change in pain score from baseline to Day 10

  Baseline to Day 10

• Change in discomfort score from baseline to Day 10

  Baseline to Day 10

• Change in otorrhea score from baseline to Day 10

  Baseline to Day 10

Study Arms (2)

nigella sativa

EXPERIMENTAL

Participants in this group will receive Nigella sativa oil ear drops, administered as two drops into the affected ear twice daily for 10 days.

Drug: Nigella sativa oil

mometasone furoate

ACTIVE COMPARATOR

Participants in this group will receive mometasone furoate 0.1% ear drops, administered as two drops into the affected ear twice daily for 10 days.

Drug: Mometasone Furoate (MF)

Interventions

Mometasone Furoate (MF) DRUG

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

mometasone furoate

Nigella sativa oil DRUG

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

nigella sativa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic; Otitis Externa

Interventions

Mometasone Furoate; Nigella sativa oil

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Nazan Degirmenci, MD,Assoc. Prof.

CONTACT

+90(212) 523 22 88; nzndegirmenci@hotmail.com

muhammed said ekinci, resident MD

CONTACT

+90(212) 523 22 88; muhammed.ekinci@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel groups to receive either Nigella sativa oil or mometasone furoate. Outcomes will be assessed at baseline and after 10 days of treatment by a blinded evaluator.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 13, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-01

Locations

TU (1)