NCT06810752Enrolling By Invitation1 期
Thyme Honey for Management of Oral Lichen Planus: A Non- Inferiority Controlled Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- VAS score assessement
研究概览
简要总结
the study aimed to assess the effect of topical application of thyme honey in comparison to 0.1% triamcinolone acetonide oral paste on the relief of pain and clinical improvement in patients with OLP
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients clinically and histopathologically (if required) diagnosed as suffering from OLP.
- •Patients free from any visible oral lesions other than OLP.
- •Patients who agreed to take supplied medications.
- •Patients who agreed for the biopsy (when required).
排除标准
- ••Patients suffering from any systemic disease.
- •Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
- •Treatment with any oral topical medications for at least four weeks prior to the study.
- •Pregnant and lactating women.
- •In addition, no consideration was given to patients with a history of hypersensitivity to honey.
研究组 & 干预措施
Thyme Honey group
Active Comparator
Topical application of Thyme Honey
干预措施: thyme honey (Dietary Supplement)
Control group
Placebo Comparator
Topical application of Triamcinolone acetonide
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
VAS score assessement
时间窗: 1 month
Pain intensity
次要结局
- measurement of salivary level of miRna155(1 month)
研究者
研究点 (1)
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