NCT05882864尚未招募4 期
Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus
研究概览
简要总结
- Compare the clinical efficacy of topical ginger extract versus triamcinolone acetonide 0.1% for symptomatic oral lichen planus (Primary Objective).
- Investigate using immunohistochemical analysis the effect of the two different treatment modalities on FasL expression in oral lichen planus lesions (Secondary Objective).
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
- Double (Participant, Care Provider)
盲法说明
The study is designed to be a prospective randomized double blind 2 parallel arms controlled clinical trial.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, aged from 40 to 60 years.
- •Clinically proven painful Bullous/erosive (score 4) or atrophic (score 3) forms of OLP confirmed by the presence of red or erythromatous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae) (Lozada-Nur and Miranda, 1997)
- •Histopathologically, proven Bullous/erosive (score 4) or atrophic (score 3) forms of OLP confirmed by the presence of accepted histopathological criteria for lichen planus; basal cell liquefaction, band like lymphocytic infiltrate at the epithelial-stromal junction with degeneration of basal cell region (Ellis, 1967; Van der Meij and Van der Waal, 2003).
排除标准
- •History of drug induced lichenoid lesions.
- •Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using medical questionnaire guided by Cornell Medical Index (Pendleton et al., 2004).
- •Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in medical history.
- •Pregnancy or breast-feeding.
- •History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study (Swift et al., 2005).
- •Patients suffering from lichen planus skin lesions.
- •Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
- •Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied.
- •Refusing to participate in the study.
- •Vulnerable groups (handicapped, orphans and prisoners).
研究组 & 干预措施
Topical 6-Gingerol Group
Active Comparator
Group I Will include 14 patients receiving topical ginger extract 1% four times per day (after every meal and before going to bed) for eight weeks (Zakaria et al., 2020).
干预措施: 6-Gingerol (Drug)
Topical Steroid Group
Active Comparator
Group II Will include 14 patients receiving topical steroid (triamcinolone acetonide 0.1%) four times per day for eight weeks (Laeijendecker et al., 2006)
In the fourth and eighth weeks, topical anti-fungal will be applied by a third-party medical personnel to avoid 2ry candidiasis for this group.
干预措施: Triamcinolone Acetonide 0.1% Oromucosal Paste (Drug)
结局指标
主要结局
Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus
时间窗: Baseline
Analysis of 6-Gingerol gel in Management of Oral Lichen Plauns using Immunohistochemistry
次要结局
未报告次要终点
研究者
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