About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

patients with oral lichen planus

male or female patients older than 18 years of age

patients willing to participate with signed informed consent.

Disqualifiers

pregnant or lactating

had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors

were unwilling to participate in the experiment.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

156 Participants

are divided into 3 treatment groups

Group A: total glucosides of paeony treatmentActive comparator 1 intervention

Group B: photodynamic therapy treatmentActive comparator 1 intervention

Group C: glucosides of paeony and photodynamic therapy combined treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy at 1 month of treatment

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.

Time frame

1 month

Secondary outcomes

1

The curative effect at the later follow-up visit

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.

Time frame

through study completion, an average of 1 year

Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy