Efficacy of Nigella Sativa Oil in Eczematous Otitis Externa: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in objective inflammatory findings of the external ear from baseline to Day 10
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
nigella sativa
Participants in this group will receive Nigella sativa oil ear drops, administered as two drops into the affected ear twice daily for 10 days.
干预措施: Nigella sativa oil (Drug)
mometasone furoate
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.
干预措施: Mometasone Furoate (MF) (Drug)
结局指标
主要结局
Change in objective inflammatory findings of the external ear from baseline to Day 10
时间窗: 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.
次要结局
- 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)
研究者
Nazan Degirmenci
Assoc. Prof.
Bezmialem Vakif University