Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
NCT ID: NCT05973097
Last Updated: 2023-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
156 participants
INTERVENTIONAL
2023-07-30
2028-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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total glucosides of paeony treatment
Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
total glucosides of paeony treatment
Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
photodynamic therapy treatment
Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
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 are combined for the treatment
glucosides of paeony and photodynamic therapy combined treatment
Glucosides of paeony and photodynamic therapy are combined for the treatment
Interventions
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total glucosides of paeony treatment
Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
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 are combined for the treatment
Eligibility Criteria
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Inclusion Criteria
* male or female patients older than 18 years of age
* patients willing to participate with signed informed consent.
Exclusion Criteria
* had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors
* were unwilling to participate in the experiment.
18 Years
ALL
Yes
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhihui Zhang
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, , China
Countries
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Central Contacts
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Lin Zeng
Role: CONTACT
Facility Contacts
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Lin Zeng
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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PUTHM912068
Identifier Type: -
Identifier Source: org_study_id
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