Assessment of the Efficacy of Topical Applied Curcumin 1% as Alternative or Complementary to Triamcinolone Acetonate in Treatment of Oral Lichen Planus(Randomise Control Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assess Visual Analog Scale (VAS) of OLP lesion
研究概览
简要总结
to evaluate the therapeutic impact of curcumin as Alternative or Complementary to Triamcinolone Acetonate in Treatment of Oral Lichen Planus.
详细描述
Background: Oral lichen planus (OLP) is a chronic inflammatory disorder affecting the mucous membranes, believed to be an immune-mediated condition. Its persisting nature can lead to extended discomfort for those affected. The primary symptoms are pain and a burning sensation, with a potential risk of malignancy if not properly managed, necessitating lifelong clinical monitoring. Presently, OLP is considered a significant challenge due to the absence of a definitive cure.
Patients & patients: Thirty patients with oral lichen planus were divided into three groups, 10 patients each: Group A: ten patients with OLP were received topical triamcinolone acetonide. Group B: ten patients with OLP were received topical curcumin. Group C: ten patients with oral lichen planus were received topical triamcinolone acetonide combiend with topical curcumin. For six weeks. Each patient was examined at baseline,1 and 3months of therapy. Pain was scored using the visual analogue scale. Salivary level of interleukin 1 were estimated at baseline,1and 3 months' evaluation periods.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of OLP
排除标准
- •Any systemic autoimmune disease
- •Any current use of anticoagulant or antiplatelet agents (curcumin has inhibitory effects on platelet aggregations).
- •Any topical, local or systemic corticosteroids therapy during the past 3 months.
- •lichenoid reaction from medications.
- •Pregnant or lactation women.
研究组 & 干预措施
Topical triamcinolone acetonide
Group I
干预措施: topical triamcinolone acetonide (Drug)
Topical curcumin
Group II
干预措施: Topical Curcumin (Drug)
Topical triamcinolone acetonide combiend with topical curcumin
Group III
干预措施: topical triamcinolone acetonide combiend with topical curcumin (Drug)
结局指标
主要结局
Assess Visual Analog Scale (VAS) of OLP lesion
时间窗: baseline ,1 ,3 months
Qualitative.P-value \>0.05: Non significant(NS); P-value \<0.05: Significant(S); P-value\< 0.01: highly significant(HS)
Assess Oral Disease Severity Score
时间窗: at base line ,after 1,3 months
Qualitative.P-value \>0.05: Non significant(NS); P-value \<0.05: Significant(S); P-value\< 0.01: highly significant(HS)
次要结局
- Biochemical analysis of salivary interlukin 6 level using (ELISA)(baseline ,1 ,3 months)
研究者
Shaymaa Hussein Rafat Kotb
Assistant lecturer of Oral Medicine ,periodontology ,oral Diagnosis & Dental Radiology ,Sphinx university
Al-Azhar University