NCT03738176Unknown早期 1 期
The Efficacy of Topical Sesame Oil in Orabase Versus Topical Triamcinolone in Orabase on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker, Malondialdehyde [MDA] : Randomized Clinical Trial (RCT)
Mona Taha Mohammed MD0 个研究点目标入组 40 人开始时间: 2019年12月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 40
- 主要终点
- pain intensit measure
研究概览
简要总结
use seseme oil and corticosteroid topically for two groups
详细描述
- The enrolled patients will be divided randomly into two groups.
- Test group will receive topical sesame oil (3 times /day after eating) for a month.
- Control group will receive topical corticosteroid (3 times /day after eating) for a month.
- Assessment of the appearance score and severity of pain as well as the clinical parameter outcome will be done at baseline and at the end of two and four weeks and will be recorded in the patients' questionnaires & by clinical sign score . MDA will be measured at the baseline & at the end of four weeks after treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will be clinically diagnosed as having atrophic &/or erosive oral lichen planus.
- •Patients with no history of taking topical corticosteroids for the last 2 months and systemic corticosteroid for the last 6 months
- •Patients who agree to take medication and follow up .
排除标准
- •Pregnant and lactating ladies.
- •Patients with history of topical steroids during last 2 months & systemic steroids during last 6 months.
- •Patients with recent dental filling associated with the lesion or associated with recent drug administration.
- •Patient with history of diabetes or hypertension or those with positive HCV ab or HBs Ag.
研究组 & 干预措施
sesame oil in orabase
Experimental
20 gm sesame oil-80 gm CMC 3 times per day for one month
干预措施: Sesame Oil (Drug)
triamcinolone in orabase
Active Comparator
140 gm triamcinolone-50 gm Na CMC 3 times per day for one month
干预措施: triamcinolone in orabase (Drug)
结局指标
主要结局
pain intensit measure
时间窗: 4 weeks
measured by visual analogue scale where0 no pain and 10 sever pain
reduction of clinical signs measure
时间窗: 4 weeks
Thongprasom Score 5 = white striae with erosive area = 1 cm2 Score 4 = white striae with erosive area \< 1 cm2 Score 3 = white striae with erosive area \> 1 cm2 Score 2 = white striae with atrophic area \< 1 cm2 Score 1 = mild white striae only Score 0 = no lesion normal
次要结局
- Salivary level of oxidative stress biomarker (MDA)(4 weeks)
研究者
Mona Taha Mohammed MD
clinical researcher
Cairo University
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