Treatment of Oral Lichen Planus Lesions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Relief sign &symptom and clinical features
研究概览
简要总结
Oral lichen planus (OLP) is a chronic inflammatory disease whose prevalence in the general population is 0.5 -2.2%.Oral lesions in OLP are chronic, rarely undergo spontaneous remission. Patients with OLP had significantly increased risk of oral squamous cell carcinoma, irrespective of the clinical type of OLP and therapy. there is currently no cure for OLP. Previous study demonstrated a decreased antioxidant defence and increased oxidative damage to lipids.DNA and proteins in lichen planus. This oxidative modifications point to pathophysiological alterations mainly within the basal cell layers of epidermis and at the dermoepidermal junction. Purslane is an excellent source of vitamin A,C and E and essential amino acids, has been described as a power food of the future because of its high nutritive and antioxidant properties. The purpose of the study was to determined the efficacy of Purslane in the treatment of oral lichen planus.
详细描述
Oral lichen planus is a chronic common inflammatory disorder affecting stratified squamous epithelia. The majority problem of OLP is development of oral squamous cell carcinoma , irrespective of the clinical type of OLP and therapy. Previous study demonstrated a decreased antioxidant defence and increased oxidative damage to lipids, DNA and proteins in lichen planus .This oxidative modifications point to pathophysiological alterations mainly within the basal cell layers of epidermis and at the dermoepidermal junction. So oxidative stress could be effective in pathogenesis of OLP. Purslane is an excellent source of vitamin A,C and E and essential amino acids, has been described as a power food of the future because of its high nutritive and antioxidant properties. Purslane also decreased the level of TNF-α and IL6, that are responsible for up-regulated adhesion molecules (in OLP lymphocyte T (T cell) recruited and retained in sub mucosa through receptors to endothelial adhesion molecule. and basal keratinocytes undergo apoptosis). The purpose of the study was to determined the efficacy of Purslane in the treatment of oral lichen planus.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirmed symptomatic oral lichen planus: WHO histological criteria in combination with clinical appearance will be used for diagnosis
- •Patients who had symptoms such as burning sensation, pain
- •Patients not on any immunosuppressive or immunomodulatory treatment. In case they were,then such treatment should be stopped and a washout period of 1 month was given.
- •Patients of both sexes between 30 to 70 year's old
- •Patients who gave written informed consent
- •Patients who were willing for evaluation in second week after therapy and every 1 month up to 6 months
排除标准
- •The presence of histological signs of dysplasia
- •Patients suffering from any localized or systemic disease
- •Renal disease patients
- •Pregnant patients
- •Patients who can not continue the study for private or social reasons
- •Patients who used lichenoid reaction including drugs
研究组 & 干预措施
1
Patients with oral lichen planus
干预措施: Purslane 235mg/day in one dosage (Drug)
结局指标
主要结局
Relief sign &symptom and clinical features
时间窗: (every 1 month up to 6months)
次要结局
- Relief sign &symptom and clinical features((time frame6 months))