Topical Application of Curcumin Incorporated in Orabase in OSMF Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in OSMF lesion
研究概览
简要总结
Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised of curcumin, demethoxy curcumin and bisdemethoxycurcumin.
详细描述
Anti-inflammatory mechanisms implicated in the anticarcinogenic potential of curcumin include: (1) inhibition of NF-κB and COX-2 (increased levels of COX-2 are associated with many cancer types); (2)inhibition of arachidonic acid metabolism via lipoxygenase and scavenging of free radicals generated in this pathway; (3) decreased expression of inflammatory cytokines IL-1b, IL-6, and TNF-a, resulting in growth inhibition of cancer cell lines; and (4) down-regulation of enzymes, such as protein kinase C, that mediate inflammation and tumor-cell proliferation.
Curcumin's potent anti-oxidant and free-radical quenching properties play an important role in the inhibitory effects of the compound on the initial stages of carcinogenesis. Antioxidants are implicated in the pathogenesis of OSMF and hence this preparation may be helpful in resolution of this lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects showing classic clinical signs of OSMF and not under any intervention for the same will be included.
排除标准
- •Subjects who are receiving or have received any form of therapy in the six month period leading to the study will be excluded.
研究组 & 干预措施
Curcumin Arm
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals.
干预措施: Curcumin Arm (Drug)
结局指标
主要结局
Reduction in OSMF lesion
时间窗: up to 6 months
The number of bands and the consistency of the lesion will be evaluated at designated time intervals using appropriate indices.
次要结局
- Jaw Opening(up to 6 months)
研究者
Dr R Viswa Chandra
Ethics Committee Investigator
SVS Institute of Dental Sciences