Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-05 @ 8:37 AM
Study NCT ID:
NCT01731756
Status:
COMPLETED
Last Update Posted:
2014-05-05
First Post:
2012-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical 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': 'D020156', 'term': 'Salicylic Acid'}, {'id': 'D010577', 'term': 'Petrolatum'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-02', 'studyFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2012-11-18', 'lastUpdatePostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in palmer arsenical keratosis', 'timeFrame': '0 week (baseline), 12 weeks (end)', 'description': 'Size and number of keratotic lesions will be reduced. These will be expressed in score.'}], 'secondaryOutcomes': [{'measure': 'Changes in arsenic level in nail', 'timeFrame': '0 week (baseline), 12 weeks (end)', 'description': 'Arsenic level in nail of the patient will be decrease. Total arsenic level will be estimated by atomic fluorescence spectrometer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Palm', 'Arsenic', 'Keratosis', 'Salicylic acid', 'Azadirachta indica', 'Neem'], 'conditions': ['Arsenical Keratosis']}, 'descriptionModule': {'briefSummary': 'Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized, double-blind, placebo-control trial', 'detailedDescription': 'The objective of this study is to evaluate the effectiveness of topical administration of the Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated water for more than six months. They will be divided into two groups each will consist of twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid ointment . Water and nail sample will be collected before starting recruitment to confirm diagnosis. Then again nail sample will be collected before and after the study to see the level of arsenic in skin. Effects will be observed after every two weeks and change will be detected as nil, mild reduction, moderate reduction and fully cured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Palmer arsenical keratosis\n* Drinking arsenic contaminated water (\\>50 ppb) for more than six months\n* Patient voluntarily agree to participate\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactating mother\n* Diabetes mellitus\n* Rheumatoid arthritis\n* Systemic lupus erythematosus\n* Psoriasis\n* Bowen's disease"}, 'identificationModule': {'nctId': 'NCT01731756', 'briefTitle': 'Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis', 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': 'Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'BSMMU-003-CT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palmer arsenical keratosis (study)', 'description': 'Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks', 'interventionNames': ['Other: Leaf extract of A. indica', 'Drug: Salicylic Acid (6%)', 'Other: Petroleum jelly']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Palmer arsenical keratosis (control)', 'description': 'Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks', 'interventionNames': ['Drug: Salicylic Acid (6%)', 'Other: Petroleum jelly']}], 'interventions': [{'name': 'Leaf extract of A. indica', 'type': 'OTHER', 'description': 'Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.', 'armGroupLabels': ['Palmer arsenical keratosis (study)']}, {'name': 'Salicylic Acid (6%)', 'type': 'DRUG', 'description': 'Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.', 'armGroupLabels': ['Palmer arsenical keratosis (control)', 'Palmer arsenical keratosis (study)']}, {'name': 'Petroleum jelly', 'type': 'OTHER', 'description': 'Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.', 'armGroupLabels': ['Palmer arsenical keratosis (control)', 'Palmer arsenical keratosis (study)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Mir Misbahuddin, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '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', 'investigatorFullName': 'Prof. Mir Misbahuddin', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}