<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03011658</url>
  </required_header>
  <id_info>
    <org_study_id>PMVIDS&amp;RC/IEC/OMR/DN/0004-15</org_study_id>
    <nct_id>NCT03011658</nct_id>
  </id_info>
  <brief_title>Serum Cortisol Levels in Patients With Anxiety and Depression With Symptomatic Oral Lichen Planus</brief_title>
  <official_title>Assessment of Anxiety and Depression in Symptomatic Oral Lichen Planus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a&#xD;
      still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown&#xD;
      prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian&#xD;
      population. 75% of patients with cutaneous lichen planus also experience oral lesions and may&#xD;
      be precipitated or exacerbated by psychosocial stressors.&#xD;
&#xD;
      In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in&#xD;
      the body, the most common effect of which is increased cortisol level in blood. This hormone&#xD;
      is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of&#xD;
      carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a decisive&#xD;
      index in stressful situations.&#xD;
&#xD;
      This study is intended to correlate the serum cortisol levels with anxiety and depression in&#xD;
      patients with symptomatic oral lichen planus. This study attempts to evaluate psychological&#xD;
      anxiety and depression in oral lichen planus subjects using Hospital Anxiety and Depression&#xD;
      Scale ( HADS) and correlating with their serum cortisol levels.&#xD;
&#xD;
      To understand and explore the etiopathogenesis for better management of oral lichen planus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a&#xD;
      still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown&#xD;
      prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian&#xD;
      population. 75% of patients with cutaneous lichen planus also experience oral lesions and may&#xD;
      be precipitated or exacerbated by psychosocial stressors.&#xD;
&#xD;
      In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in&#xD;
      the body, the most common effect of which is increased cortisol level in blood. This hormone&#xD;
      is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of&#xD;
      carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a decisive&#xD;
      index in stressful situations.&#xD;
&#xD;
      This study is intended to correlate the serum cortisol levels with anxiety and depression in&#xD;
      patients with symptomatic oral lichen planus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum- cortisol levels from venous blood.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression scale</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Oral Lichen Planus Related Stress</condition>
  <arm_group>
    <arm_group_label>GROUP A</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>venepuncture</intervention_name>
    <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</description>
    <arm_group_label>GROUP A</arm_group_label>
    <arm_group_label>GROUP B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Clinical features with burning sensation on eating spicy food.&#xD;
&#xD;
          -  Patients with symptomatic Oral lichen planus evaluated clinically and histologically.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients not willing to be part of the study.&#xD;
&#xD;
          -  Patients who are on corticosteroid therapy.&#xD;
&#xD;
          -  Patients with endocrinal disorders which can alter adrenal gland function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>NALLAN chaitanya, MDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>READER</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Panineeya Institute of Dental Sciences</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</investigator_affiliation>
    <investigator_full_name>NALLAN CHAITANYA</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lichen Planus, Oral</mesh_term>
    <mesh_term>Lichen Planus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03011658
org study id: PMVIDS&RC/IEC/OMR/DN/0004-15
nct id: NCT03011658
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Serum- cortisol levels from venous blood.
time frame: 1 year
measure: Hospital Anxiety and Depression scale
time frame: 1 year
arm group label: GROUP A
arm group type: Placebo Comparator
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 group label: GROUP B
arm group type: Other
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: venepuncture
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
arm group label: GROUP A
arm group label: GROUP B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: NALLAN chaitanya, MDS
role: Principal Investigator
affiliation: READER
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
investigator full name: NALLAN CHAITANYA
investigator title: Principal investigator
mesh term: Lichen Planus, Oral
mesh term: Lichen Planus
sharing ipd: No