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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Anxiety and Depression in Symptomatic Oral Lichen Planus

Conditions
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Oral Lichen Planus Related Stress

Intervention / Treatment
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* Procedure: venepuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: GROUP A<br>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 | Procedure: venepuncture<br>* for both the groups, HADS questionnaire will be administered to assess the levels of anxiety and depression. The placebo group ( group A) will not be having subjects suffering from oral lichen planus<br>|
| Other: GROUP B<br>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 | Procedure: venepuncture<br>* for both the groups, HADS questionnaire will be administered to assess the levels of anxiety and depression. The placebo group ( group A) will not be having subjects suffering from oral lichen planus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum- cortisol levels from venous blood. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression scale |  | 1 year |