Clinical Evaluation of Glutamine Combined With Topical Corticosteroids in the Treatment of Erosive Oral Lichen Planus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in oral lichen planus lesions severity
研究概览
简要总结
Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Glutamine promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.
详细描述
Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Recently, increased oxidative stress has been implicated in the pathogenesis of erosive oral lichen planus (EOLP). Glutamine is a source of energy for fibroblasts, immunocompetent cells, and intestinal epithelial cells involved in collagen production. It promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.
The aim of this study is to evaluate the effect of Glutamine combined with topical corticosteroid in the treatment of oral erosive LP.
Thirty patients with a confirmed clinical and histopathologic diagnosis of OLP recruited in this study and divided into 2 equal groups, each consisting of 15 subjects. Group 1 consists of patients treated with topical steroids plus antifungal (conventional therapy); Group 2 consists of patients treated with Glutamine combined with topical steroids plus antifungal.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients clinically and histopathologically diagnosed to be suffering from EOLP.
- •Patients who had symptoms i.e. pain and/or burning sensation secondary to EOLP.
- •Patients under stressful life conditions as evidenced by ISMA-UK Stress Questionnaire
- •Males and Females with an age ranging from 30-60years
排除标准
- •Patients suspected to have a lichenoid drug reaction or lichenoid contact allergy.
- •Patients suffering from any systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
- •Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
研究组 & 干预措施
conventional therapy
topical corticosteroid plus antifungal
干预措施: Miconazole Oral gel (Drug)
conventional therapy
topical corticosteroid plus antifungal
干预措施: Kenacort in orabase (Drug)
Glutamine with a topical corticosteroid plus antifungal
Glutamine therapy in combination with a topical corticosteroid plus antifungal
干预措施: Glutamine Cap/Tab (Drug)
Glutamine with a topical corticosteroid plus antifungal
Glutamine therapy in combination with a topical corticosteroid plus antifungal
干预措施: Miconazole Oral gel (Drug)
Glutamine with a topical corticosteroid plus antifungal
Glutamine therapy in combination with a topical corticosteroid plus antifungal
干预措施: Kenacort in orabase (Drug)
结局指标
主要结局
Change in oral lichen planus lesions severity
时间窗: at baseline, 1 months and 3 months
Mucosal lesion severity score 0: no lesion score 1: white lesion score 2:atrophy/erosion intermixed or not with white lesion score 3: ulceration intermixed or not with white lesion
次要结局
- Change in pain level(at baseline, 1 months and 3 months)
研究者
Hams Hamed Abdelrahman
Assistant lecturer
Alexandria University