Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: total glucosides of paeony treatment, photodynamic therapy treatment, glucosides of paeony and photodynamic therapy combined treatment.
- Who it may be relevant to
- Registry conditions: Oral Lichen Planus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study of Combined Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
Overview
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.
Interventions
- Drug total glucosides of paeony treatment
Total glucosides of paeony capsules were given 0.6 g once, 3 times a day. - Other photodynamic therapy treatment
Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode. - Other glucosides of paeony and photodynamic therapy combined treatment
Glucosides of paeony and photodynamic therapy are combined for the treatment
Primary outcome measures
- Efficacy at 1 month of treatment [Time frame: 1 month]
Secondary outcome measures (1)
- The curative effect at the later follow-up visit [Time frame: through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Publications
- van der Meij EH, van der Waal I. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications. J Oral Pathol Med. 2003 Oct;32(9):507-12. doi: 10.1034/j.1600-0714.2003.00125.x. PMID 12969224
- Li J, Chen CX, Shen YH. Effects of total glucosides from paeony (Paeonia lactiflora Pall) roots on experimental atherosclerosis in rats. J Ethnopharmacol. 2011 May 17;135(2):469-75. doi: 10.1016/j.jep.2011.03.045. Epub 2011 Mar 29. PMID 21453765
- Villa A, Sankar V, Bassani G, Johnson LB, Sroussi H. Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jun;129(6):585-590. doi: 10.1016/j.oooo.2020.02.014. Epub 2020 Mar 25. PMID 32220595
- Lavaee F, Shadmanpour M. Comparison of the effect of photodynamic therapy and topical corticosteroid on oral lichen planus lesions. Oral Dis. 2019 Nov;25(8):1954-1963. doi: 10.1111/odi.13188. Epub 2019 Oct 2. PMID 31478283
- Zhou L, Cao T, Wang Y, Yao H, Du G, Tian Z, Tang G. Clinical observation on the treatment of oral lichen planus with total glucosides of paeony capsule combined with corticosteroids. Int Immunopharmacol. 2016 Jul;36:106-110. doi: 10.1016/j.intimp.2016.03.035. Epub 2016 Apr 26. PMID 27129091
Identifiers
NCT: NCT05973097 · PUTHM912068