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临床试验/NCT03793634
NCT03793634Unknown1 期

Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus

Cairo University0 个研究点目标入组 37 人开始时间: 2019年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
37
主要终点
Pain using Numerical rating scale

研究概览

简要总结

Using of herbal medications as topical chamomile which has antioxidant, anti-inflammatory and anticarcinogenesis effect with little side effects is the aim for the future treatment of OLP.

详细描述

Oral lichen planus (OLP) is a chronic inflammatory T cell mediated autoimmune disease that affects skin and any mucous membrane particularly oral mucosa.The patient complains of burning sensation, pain; interference with eating, swallowing and speech leading to worsening of quality of life.Oxidative stress plays a role in pathomechanism of OLP disease. Enzymatic and non- enzymatic anti-oxidants act as a physiological guard against reactive oxygen species (ROS) and cytokine-mediated toxicity.Herbal treatment is the aim of the future therapy.Chamomile has anti-oxidant , anti-inflammatory effect and accelerate healing.

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)

盲法说明

The supervisor(AA) will be blind. The principle investigator(EN) will supply the patient with the treatment.

The supervisor (AA) will assess the clinical parameters before treatment , between visits and at the end of the treatment.

Statistician will be blind. Double - blind study.

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic OLP.
  • Patients with no history of taking corticosteroids for the last 6 months.
  • Patients who agree to take medication.
  • Medically free

排除标准

  • Patients with oral lesions other than OLP.
  • Lichenoid reaction .
  • Pregnant females and lactation.

研究组 & 干预措施

topical chamomile

Experimental

herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.

干预措施: topical chamomile (Drug)

Topical Triamcinolone Acetonide

Active Comparator

topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.

干预措施: topical chamomile (Drug)

结局指标

主要结局

Pain using Numerical rating scale

时间窗: 1 month

Pain measure using Numerical rating scale

次要结局

  • clinical sign score(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esraa Nashat

11 saraya st - manial - cairo

Cairo University

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