Cepharanthine and Oral Lichen Planus Efficacy (COLE) study: protocol for a multicentre randomised controlled study assessing the efficacy and safety of cepharanthine with topical corticosteroids in oral lichen planus.

ABSTRACT:

Introduction

Oral lichen planus (OLP) is a chronic, inflammatory oral condition leading to a range of symptoms from mild discomfort to severe pain, affecting patients' quality of life. Standard therapy involves the use of topical corticosteroids, although some patients respond insufficiently or develop resistance to therapy. We aim to explore if adding cepharanthine, an herbal extract from Stephania cepharantha Hayata, can enhance the efficacy of corticosteroid therapy in symptomatic OLP.

Methods and analysis

This open-label, parallel-group, multi-centre, randomised controlled study will be conducted at three Japanese hospitals. It will compare safety and efficacy of integrated oral cepharanthine and corticosteroid therapy versus standard corticosteroid therapy. 50 sy

SUBMITTER: Yagyuu T 

PROVIDER: S-EPMC10432648 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature