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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05997173
Other study ID # BMU81800920402
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 7, 2020
Est. completion date February 2025

Study information

Verified date September 2022
Source Peking University Third Hospital
Contact Zhihui Zhang
Phone 010-82266125
Email wisdomzhangzhihui@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Oral lichen planus (OLP) is a common chronic inflammatory disease of Oral mucosa. The pathogenesis of OLP is not clear, and there is no effective method to cure it. In vitro, previous studies have shown that oral mucosal mesenchymal stem cell cells (MSCs) can secrete Ido, which is involved in the pathogenesis of OLP. It has been proved that mental disorders such as depression and anxiety play an important role in the pathogenesis and treatment of OLP. Mental stress factors can cause abnormal changes of inflammatory factors, leading to immune dysfunction, which is also one of the main causes of OLP. In this study, we integrated the advantages of stomatology, psychiatry, neurobiology and traditional Chinese medicine, focused on the clinical problems of mental disorders with oral mucosal comorbidity, and assessed the depressive and anxiety status of OLP patients, so as to improve the therapeutic effect of OLP.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Control
Investigation of scale of control
Non erosive OLP
Investigation of cale of non erosive OLP patients
Erosive OLP
Investigation of cale of erosive OLP patients

Locations

Country Name City State
China Peking University Third Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27. — View Citation

Hashmi AM, Butt Z, Umair M. Is depression an inflammatory condition? A review of available evidence. J Pak Med Assoc. 2013 Jul;63(7):899-906. — View Citation

Nitzan U, Carmeli G, Chalamish Y, Braw Y, Kirsch I, Shefet D, Krieger I, Mendlovic S, Bloch Y, Lichtenberg P. Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial. J Affect Disord. 2020 Nov 1;276:707-710. doi: 10.1016/j.jad.2020.07.077. Epub 2020 Jul 21. — View Citation

Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 2012 Mar 17;379(9820):1056-67. doi: 10.1016/S0140-6736(11)60871-4. Epub 2012 Feb 2. — View Citation

Vilar-Villanueva M, Gandara-Vila P, Blanco-Aguilera E, Otero-Rey EM, Rodriguez-Lado L, Garcia-Garcia A, Blanco-Carrion A. Psychological disorders and quality of life in oral lichen planus patients and a control group. Oral Dis. 2019 Sep;25(6):1645-1651. doi: 10.1111/odi.13106. Epub 2019 May 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The scores of the scale with the symptoms and signs of the disease Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms. During the initial diagnosis,through study completion, an average of 1 year
Secondary Immune inflammatory response Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms. During the initial diagnosis,through study completion, an average of 1 year
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