Serum Cortisol Levels in Patients With Anxiety and Depression With Symptomatic Oral Lichen Planus

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Status: Completed

Conditions: Oral Lichen Planus Related Stress

Treatments: Procedure: venepuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03011658

PMVIDS&RC/IEC/OMR/DN/0004-15

Details and patient eligibility

About

Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian population. 75% of patients with cutaneous lichen planus also experience oral lesions and may be precipitated or exacerbated by psychosocial stressors.

In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in the body, the most common effect of which is increased cortisol level in blood. This hormone is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a decisive index in stressful situations.

This study is intended to correlate the serum cortisol levels with anxiety and depression in patients with symptomatic oral lichen planus. This study attempts to evaluate psychological anxiety and depression in oral lichen planus subjects using Hospital Anxiety and Depression Scale ( HADS) and correlating with their serum cortisol levels.

To understand and explore the etiopathogenesis for better management of oral lichen planus.

Full description

Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian population. 75% of patients with cutaneous lichen planus also experience oral lesions and may be precipitated or exacerbated by psychosocial stressors.

In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in the body, the most common effect of which is increased cortisol level in blood. This hormone is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a decisive index in stressful situations.

This study is intended to correlate the serum cortisol levels with anxiety and depression in patients with symptomatic oral lichen planus.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Clinical features with burning sensation on eating spicy food.
• Patients with symptomatic Oral lichen planus evaluated clinically and histologically.

Exclusion criteria:

• Patients not willing to be part of the study.
• Patients who are on corticosteroid therapy.
• Patients with endocrinal disorders which can alter adrenal gland function.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

GROUP A

Placebo Comparator group

Description:

5 ml of venous blood will be obtained from this group who do not have oral lichen planus and suffering from anxiety and/or depression. They will be administered a HADS standard questionnaire and their stress related issues calculated accordingly. This group has 30 patients totally

Treatment:

Procedure: venepuncture

GROUP B

Other group

Description:

The group has 30 oral symptomatic lichen planus diagnosed patients also suffering with anxiety and/or depression. 5 ml of venous blood will be obtained from them for serum cortisol level analysis. HADS questionnaire will be administered for this group for evaluation of levels of anxiety and depression

Treatment:

Procedure: venepuncture