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

Oral Lichen Planus Related Stress Clinical Trial

Official title:

Assessment of Anxiety and Depression in Symptomatic Oral Lichen Planus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011658
• Other study ID #: PMVIDS&RC/IEC/OMR/DN/0004-15
• Status: Completed
• Phase: N/A
• First received: January 4, 2017
• Last updated: December 18, 2017
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus Related Stress

Intervention

Procedure:
• venepuncture
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

Locations

Country	Name	City	State
India	Panineeya Institute of Dental Sciences	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum- cortisol levels from venous blood.		1 year
Secondary	Hospital Anxiety and Depression scale		1 year