Serum Cortisol Levels in Patients With Anxiety and Depression With Symptomatic Oral Lichen Planus
Primary Purpose
Oral Lichen Planus Related Stress
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
venepuncture
Sponsored by
About this trial
This is an interventional diagnostic trial for Oral Lichen Planus Related Stress
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.
Sites / Locations
- Panineeya Institute of Dental Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Other
Arm Label
GROUP A
GROUP B
Arm 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
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
Outcomes
Primary Outcome Measures
Serum- cortisol levels from venous blood.
Secondary Outcome Measures
Hospital Anxiety and Depression scale
Full Information
NCT ID
NCT03011658
First Posted
January 4, 2017
Last Updated
December 18, 2017
Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT03011658
Brief Title
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
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus Related Stress
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GROUP A
Arm Type
Placebo Comparator
Arm 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
Arm Title
GROUP B
Arm Type
Other
Arm 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
Intervention Type
Procedure
Intervention Name(s)
venepuncture
Intervention Description
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 Outcome Measure Information:
Title
Serum- cortisol levels from venous blood.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression scale
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NALLAN chaitanya, MDS
Organizational Affiliation
READER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Panineeya Institute of Dental Sciences
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500060
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Serum Cortisol Levels in Patients With Anxiety and Depression With Symptomatic Oral Lichen Planus
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