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Completed

NCT Number: NCT03011658

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

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.

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Key information

Conditions

Oral Lichen Planus Related Stress

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Panineeya Institute of Dental Sciences

Hyderabad, Telangana, 500060, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venepuncture

Procedure

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

Primary outcomes

  1. Serum- cortisol levels from venous blood.

    Time frame: 1 year

Secondary outcomes

  1. Hospital Anxiety and Depression scale

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Other

Registry information

Official study title

Assessment of Anxiety and Depression in Symptomatic Oral Lichen Planus

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 5, 2017
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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