Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

Not Applicable

Recruiting

Interventions: Drug: total glucosides of paeony treatment
Other: photodynamic therapy treatment
Other: glucosides of paeony and photodynamic therapy combined treatment

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
total glucosides of paeony treatment	total glucosides of paeony treatment	Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
photodynamic therapy treatment	photodynamic therapy treatment	Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
glucosides of paeony and photodynamic therapy combined treatment	glucosides of paeony and photodynamic therapy combined treatment	Glucosides of paeony and photodynamic therapy are combined for the treatment

Primary Outcome Measures

Name	Time	Method
Efficacy at 1 month of treatment	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.

Secondary Outcome Measures

Name	Time	Method
The curative effect at the later follow-up visit	through study completion, an average of 1 year	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.

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