Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-21 @ 11:11 AM
Study NCT ID:
NCT01748669
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2012-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007642', 'term': 'Keratosis'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C038491', 'term': 'allyl sulfide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-11', 'studyFirstSubmitDate': '2012-12-11', 'studyFirstSubmitQcDate': '2012-12-11', 'lastUpdatePostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the clinical symptom of keratosis in palm', 'timeFrame': '0 week (baseline) to 12 weeks (end)'}], 'secondaryOutcomes': [{'measure': 'Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment', 'timeFrame': '0 week (baseline), 12 weeks (end)'}, {'measure': 'Adverse effects following treament', 'timeFrame': '0 week (baseline), 12 weeks (end)'}, {'measure': 'Change in the amount of arsenic in nail', 'timeFrame': '0 week (baseline), 20 weeks (end)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arsenic', 'Arsenicosis', 'Garlic oil', 'Keratosis'], 'conditions': ['Chronic Arsenic Poisoning']}, 'descriptionModule': {'briefSummary': 'Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic load and clinical symptoms. Similar treatment with similar number of arsenic exposed controls and healthy volunteers will be included for comparison.', 'detailedDescription': 'Thousands of Bangladeshi are suffering from arsenic-induced keratosis affecting palms and soles. Palmer keratosis, particularly in young female, affects the socioeconomic condition. Till today there is no effective treatment.\n\nTwenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil in soft capsule (10 mg/day) orally for 12 weeks. Similar treatment will be given to 20 arsenic exposed controls and 20 healthy volunteers for comparison. The aim of this study is to examine the effectiveness of oral administration of garlic oil to reduce body arsenic load and clinical symptoms of arsenical palmer keratosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Patients):\n\n* history of taking arsenic contaminated water (\\>50 ppb) for more than 6 months\n* patients having mild to moderate arsenical keratosis present on palm of the hand\n* patients those voluntarily agree to participate\n\nInclusion Criteria (Arsenic exposed controls):\n\n* family member of the patient\n* drinking arsenic contaminated water from the same source as patient\n* those voluntarily agree to participate\n* no sign/symptom of palmer keratosis\n\nInclusion Criteria (Healthy volunteers):\n\n* drinking arsenic safe water (\\<50 ppb)\n* those voluntarily agree to participate\n\nExclusion Criteria:\n\n* pregnancy\n* lactating mother\n* patient receiving treatment of arsenicosis\n* any other chronic disease like tuberculosis, diabetes mellitus, bronchial asthma'}, 'identificationModule': {'nctId': 'NCT01748669', 'briefTitle': 'Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis', 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': 'Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis', 'orgStudyIdInfo': {'id': 'BSMMU-005-CT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients of palmer arsenical keratosis', 'description': 'One soft capsule of garlic oil (10 mg) daily for 12 weeks', 'interventionNames': ['Dietary Supplement: Garlic oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arsenic exposed controls', 'description': 'One soft capsule of garlic oil (10 mg) daily for 12 weeks', 'interventionNames': ['Dietary Supplement: Garlic oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heathy volunteers', 'description': 'One soft capsule of garlic oil (10 mg) daily for 12 weeks', 'interventionNames': ['Dietary Supplement: Garlic oil']}], 'interventions': [{'name': 'Garlic oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration', 'armGroupLabels': ['Arsenic exposed controls', 'Heathy volunteers', 'Patients of palmer arsenical keratosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'Bangabandhu Sheikh Mujib Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Mir Misbahuddin, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. and Chairman, Department of Pharmacology', 'investigatorFullName': 'Prof. Mir Misbahuddin', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}