跳至主要内容
临床试验/NCT05997173
NCT05997173招募中不适用

The Regulatory Role of Immune Response in Oral Lichen Planus With Mental Disorders

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
The scores of the scale with the symptoms and signs of the disease

研究概览

简要总结

Oral lichen planus (OLP) is a common chronic inflammatory disease of Oral mucosa. The pathogenesis of OLP is not clear, and there is no effective method to cure it. In vitro, previous studies have shown that oral mucosal mesenchymal stem cell cells (MSCs) can secrete Ido, which is involved in the pathogenesis of OLP. It has been proved that mental disorders such as depression and anxiety play an important role in the pathogenesis and treatment of OLP. Mental stress factors can cause abnormal changes of inflammatory factors, leading to immune dysfunction, which is also one of the main causes of OLP. In this study, we integrated the advantages of stomatology, psychiatry, neurobiology and traditional Chinese medicine, focused on the clinical problems of mental disorders with oral mucosal comorbidity, and assessed the depressive and anxiety status of OLP patients, so as to improve the therapeutic effect of OLP.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

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

入选标准

  • patients with oral lichen planus
  • male or female patients older than 18 years of age
  • patients willing to participate with signed informed consent.

排除标准

  • pregnant or lactating
  • had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors
  • were unwilling to participate in the experiment.

结局指标

主要结局

The scores of the scale with the symptoms and signs of the disease

时间窗: During the initial diagnosis,through study completion, an average of 1 year

Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.

次要结局

  • Immune inflammatory response(During the initial diagnosis,through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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