Clinical Study of Combined Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Efficacy at 1 month of treatment
研究概览
简要总结
Oral lichen planus (OLP) is a common chronic inflammatory disease of the oral mucosa and is considered a precancerous condition. It is characterized by white reticular changes in the oral mucosa, which can progress to erosions and cause pain in severe cases. The pathogenesis of OLP is still unclear, but it is believed to be a T-lymphocyte-mediated autoimmune disease. Currently, only symptomatic treatments are available, and there is no definitive cure.
In this project, we plan to use TCM differentiation to categorize OLP patients and conduct a randomized controlled clinical trial to demonstrate the enhanced therapeutic effect of paeoniflorin combined with photodynamic therapy for OLP. The implementation of this project will provide new insights into the clinical management of OLP, improve our understanding of the treatment mechanisms, and have important theoretical and clinical implications.
详细描述
Paeoniflorin, a compound extracted from the traditional Chinese medicine, has anti-inflammatory and immunomodulatory effects. Photodynamic therapy is a novel local treatment approach, where photosensitizers selectively target and destroy diseased cells. Both treatments have shown efficacy in treating OLP when used individually.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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.
研究组 & 干预措施
total glucosides of paeony treatment
Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
干预措施: total glucosides of paeony treatment (Drug)
photodynamic therapy treatment
Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
干预措施: photodynamic therapy treatment (Other)
glucosides of paeony and photodynamic therapy combined treatment
Glucosides of paeony and photodynamic therapy are combined for the treatment
干预措施: glucosides of paeony and photodynamic therapy combined treatment (Other)
结局指标
主要结局
Efficacy at 1 month of treatment
时间窗: 1 month
According to the trial standard for evaluating the efficacy of atrophic and erosive oral lichen planus (OLP), the evaluation includes both objective and subjective measures. Objective measure: The size of the lesion is measured by an observer. The physician records and takes photographs of the lesion, noting the location, color, and changes in the area. The color and area changes of the lesion are compared and determined based on the photographic records. Subjective measure: Visual analogue scales (VAS) are used, which consist of 10 levels. The pain level is recorded, and the assessment is done by the patient.
次要结局
- The curative effect at the later follow-up visit(through study completion, an average of 1 year)