Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

Peking University

Status: Enrolling

Conditions: Oral Lichen Planus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05973097

PUTHM912068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

156 participants in 3 patient groups

total glucosides of paeony treatment

Active Comparator group

Description:

Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.

Treatment:

Drug: total glucosides of paeony treatment

photodynamic therapy treatment

Active Comparator group

Description:

Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.

Treatment:

Other: photodynamic therapy treatment

glucosides of paeony and photodynamic therapy combined treatment

Experimental group

Description:

Glucosides of paeony and photodynamic therapy are combined for the treatment

Treatment:

Other: glucosides of paeony and photodynamic therapy combined treatment