Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 11:44 AM
Study NCT ID:
NCT04971434
Status:
UNKNOWN
Last Update Posted:
2021-07-21
First Post:
2021-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015669', 'term': 'Acupuncture Points'}], 'ancestors': [{'id': 'D016740', 'term': 'Meridians'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2021-07-11', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'high-density lipoprotein', 'timeFrame': 'It will be measured after 4 weeks of treatment', 'description': 'serum lipid'}, {'measure': 'low-density lipoprotein', 'timeFrame': 'It will be measured after 4 weeks of treatment', 'description': 'serum lipid'}, {'measure': 'cholesterol', 'timeFrame': 'It will be measured after 4 weeks of treatment', 'description': 'serum lipid'}, {'measure': 'triglyceride', 'timeFrame': 'It will be measured after 4 weeks of treatment', 'description': 'serum lipid'}], 'secondaryOutcomes': [{'measure': 'c reactive protein', 'timeFrame': 'It will be measured after 4 weeks of treatment', 'description': 'it will be measured in plasma'}, {'measure': 'blood glucose', 'timeFrame': 'It will be measured after 4 weeks of treatment', 'description': 'fasting gluocse'}, {'measure': 'blood pressure', 'timeFrame': 'It will be measured after 4 weeks of treatment', 'description': 'it will be measure with manual manometer'}, {'measure': 'rate of pulse', 'timeFrame': 'It will be measured after 4 weeks of treatment', 'description': 'it will be measured at radial artery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fatty Liver']}, 'descriptionModule': {'briefSummary': 'Every-two-week applied cupping (with scarification) session within one month on back of upper thorax is not compared previously regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) in fatty liver patients. This trial will compare the two procedure effects on cardio-metabolic risk factors in fatty liver.', 'detailedDescription': 'In fatty liver patients,every-two-week applied cupping (with scarification) session within one month on back of upper thorax for 30 patients will be compared regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) of other 30 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'genderBased': True, 'genderDescription': 'self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed Fatty liver patients by ultrasonography\n* Class I obese patients\n\nExclusion Criteria:\n\n* Cardiovascular and respiratory disorders/diseases.\n* Autoimmune disorders/diseases.\n* Pregnancy\n* Other liver disorders/diseases.'}, 'identificationModule': {'nctId': 'NCT04971434', 'briefTitle': 'Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Non-alcoholic Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping-with-scarification', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'laser', 'description': 'In fatty liver patients (30 patients), a daily application of 4-minute laser (for one month, except Fridays) on acupoint number 25,40,36 of stomach meridian, acupoint number 3 of liver meridian, acupoint number 6 of spleen meridian,acupoint number 9.12,4 of conception vessel meridian, acupoint number 14 of governor vessel meridian, acupoint number 4, 11 of large intestine meridian, acupoint number 34 of gall bladder meridian', 'interventionNames': ['Device: laser stimulation for acupoints']}, {'type': 'EXPERIMENTAL', 'label': 'cupping with scarification', 'description': 'In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax', 'interventionNames': ['Other: cupping with scarification']}], 'interventions': [{'name': 'laser stimulation for acupoints', 'type': 'DEVICE', 'description': 'In fatty liver patients (30 patients), a daily application of 4-minute laser (for one month, except Fridays) on acupoint number 25,40,36 of stomach meridian, acupoint number 3 of liver meridian, acupoint number 6 of spleen meridian,acupoint number 9,12,4 of conception vessel meridian, acupoint number 14 of governor vessel meridian, acupoint number 4, 11 of large intestine meridian, acupoint number 34 of gall bladder meridian', 'armGroupLabels': ['laser']}, {'name': 'cupping with scarification', 'type': 'OTHER', 'description': 'In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax', 'armGroupLabels': ['cupping with scarification']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'state': 'Dokki', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ali Ismail, lecturer', 'role': 'CONTACT', 'email': 'allooka2012@gmail.com', 'phone': '02 01005154209'}], 'facility': 'Faculty of Physical Therapy Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Ali Ismail, lecturer', 'role': 'CONTACT', 'email': 'allooka2012@gmail.com', 'phone': '02 01005154209'}], 'overallOfficials': [{'name': 'Ali Ismail, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University', 'investigatorFullName': 'Ali Mohamed Ali ismail', 'investigatorAffiliation': 'Cairo University'}}}}