Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT03011658
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2017-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Cortisol Levels in Patients With Anxiety and Depression With Symptomatic Oral Lichen Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-18', 'studyFirstSubmitDate': '2017-01-04', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum- cortisol levels from venous blood.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety and Depression scale', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oral Lichen Planus Related Stress']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nThis 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.\n\nTo understand and explore the etiopathogenesis for better management of oral lichen planus.', 'detailedDescription': '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.\n\nIn 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.\n\nThis study is intended to correlate the serum cortisol levels with anxiety and depression in patients with symptomatic oral lichen planus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Clinical features with burning sensation on eating spicy food.\n* Patients with symptomatic Oral lichen planus evaluated clinically and histologically.\n\nExclusion criteria:\n\n* Patients not willing to be part of the study.\n* Patients who are on corticosteroid therapy.\n* Patients with endocrinal disorders which can alter adrenal gland function.'}, 'identificationModule': {'nctId': 'NCT03011658', 'briefTitle': 'Serum Cortisol Levels in Patients With Anxiety and Depression With Symptomatic Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre'}, 'officialTitle': 'Assessment of Anxiety and Depression in Symptomatic Oral Lichen Planus', 'orgStudyIdInfo': {'id': 'PMVIDS&RC/IEC/OMR/DN/0004-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'GROUP A', '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', 'interventionNames': ['Procedure: venepuncture']}, {'type': 'OTHER', 'label': 'GROUP B', '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', 'interventionNames': ['Procedure: venepuncture']}], 'interventions': [{'name': 'venepuncture', 'type': 'PROCEDURE', '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', 'armGroupLabels': ['GROUP A', 'GROUP B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500060', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Panineeya Institute of Dental Sciences', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'overallOfficials': [{'name': 'NALLAN chaitanya, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'READER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'NALLAN CHAITANYA', 'investigatorAffiliation': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre'}}}}