Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT04046718
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2019-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lipid Profile Response to Electroacupuncture Stimulation in Non Alcoholic Fatty Liver Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two group study, one is the study group and the other is a control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-04', 'studyFirstSubmitDate': '2019-08-03', 'studyFirstSubmitQcDate': '2019-08-03', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tri-triglycerides (mg/dl) , total cholesterol (mg/dl) , HDL (mg/dl) , LDL (mg/dl)', 'timeFrame': '6 weeks', 'description': 'lowering of total lipid profile in study group'}], 'secondaryOutcomes': [{'measure': 'weight (kg) , height (m), BMI (kg/m2)', 'timeFrame': '1st week', 'description': 'calculation of body mass index'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fatty Liver , Electroacupuncture, Lipid Profile']}, 'referencesModule': {'references': [{'pmid': '31657614', 'type': 'BACKGROUND', 'citation': 'Draz RS, Serry ZMH, Rahmy AF, El Bardesi MS, Taha MM. Electroacupuncture Versus Aerobic Interval Training on Liver Functions in Patients with Nonalcoholic Fatty Liver. J Altern Complement Med. 2020 Jan;26(1):51-57. doi: 10.1089/acm.2019.0182. Epub 2019 Oct 29.'}], 'seeAlsoLinks': [{'url': 'https://orcid.org/0000-0003-4089-323X', 'label': 'my orcid account ID'}]}, 'descriptionModule': {'briefSummary': 'sixty female patients suffering from non-alcoholic fatty liver disease were randomly divided into two equal groups group 1 received electroacupuncture stimulation for 6 weeks at special points of stimulation. group 2 was a control group that received nothing without any change in lifestyle and we assed the response of lipid profile post-treatment protocol in both groupes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nnon alcoholic fatty liver BMI 30-40\n\nExclusion Criteria:\n\n* Patients with: (Hepatitis C \\& b any form of seizure'}, 'identificationModule': {'nctId': 'NCT04046718', 'briefTitle': 'Lipid Profile Response to Electroacupuncture Stimulation in Non Alcoholic Fatty Liver Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Lipid Profile Response to Electroacupuncture', 'orgStudyIdInfo': {'id': 'P.T.REC/012/001579_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'electroacupuncture', 'description': 'the study group received electroacupuncture stimulation at different points', 'interventionNames': ['Device: electro-acupuncture stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'a control group with no intervention'}], 'interventions': [{'name': 'electro-acupuncture stimulation', 'type': 'DEVICE', 'description': 'stimulation of acupoints of the liver meridian of lv3 lv14', 'armGroupLabels': ['electroacupuncture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'faculty of physical therapy Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramy Salama Draz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ramy Salama Draz', 'investigatorAffiliation': 'Cairo University'}}}}