Clinical trial NCT03011658: Serum Cortisol Levels in Patients With Anxiety and Depression With Symptomatic Oral Lichen Planus
Official title: Assessment of Anxiety and Depression in Symptomatic Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Lichen Planus Related Stress
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility 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.

Primary outcomes:
measure: Serum- cortisol levels from venous blood.
timeFrame: 1 year
Secondary outcomes:
measure: Hospital Anxiety and Depression scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Panineeya Institute of Dental Sciences
state: Telangana
Study officials:
affiliation: READER
name: NALLAN chaitanya, MDS
role: PRINCIPAL_INVESTIGATOR
References: