Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-19 @ 12:45 PM
Study NCT ID:
NCT03503903
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2018-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Wet Cupping on Reactive Oxygen Species and Antioxidants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-05', 'size': 229659, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-11T16:05', 'hasProtocol': True}, {'date': '2018-01-05', 'size': 130029, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-11T16:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TAS', 'timeFrame': '7 days', 'description': 'Total antioxidant status'}, {'measure': 'TOS', 'timeFrame': '7 days', 'description': 'Total oxidant status'}], 'secondaryOutcomes': [{'measure': 'SOD', 'timeFrame': '7 days', 'description': 'Super oxide dismutase'}, {'measure': 'CAT', 'timeFrame': '7 days', 'description': 'Catalase'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wet cupping therapy', 'antioxidant capacity'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': ". Burton, M. Smith, T. Falkenberg, Building WHO's global strategy for traditional medicine, European Journal of Integrative Medicine 7(1) (2015) 13-15."}, {'type': 'BACKGROUND', 'citation': 'M. Ahmedi, M.R. Siddiqui, The value of wet cupping as a therapy in modern medicine-An Islamic Perspective, (2014).'}, {'type': 'BACKGROUND', 'citation': 'S. El Sayed, H. Mahmoud, M. Nabo, Methods of wet cupping therapy (Al-Hijamah): in light of modern medicine and prophetic medicine, Alternative & Integrative Medicine (2013) 1-16.'}, {'pmid': '9129943', 'type': 'BACKGROUND', 'citation': 'Sies H. Oxidative stress: oxidants and antioxidants. Exp Physiol. 1997 Mar;82(2):291-5. doi: 10.1113/expphysiol.1997.sp004024.'}, {'pmid': '17051205', 'type': 'BACKGROUND', 'citation': 'Lin MT, Beal MF. Mitochondrial dysfunction and oxidative stress in neurodegenerative diseases. Nature. 2006 Oct 19;443(7113):787-95. doi: 10.1038/nature05292.'}, {'pmid': '31668556', 'type': 'DERIVED', 'citation': 'Ersoy S, Benli AR. Continue or stop applying wet cupping therapy (al-hijamah) in migraine headache:A randomized controlled trial. Complement Ther Clin Pract. 2020 Feb;38:101065. doi: 10.1016/j.ctcp.2019.101065. Epub 2019 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of Wet cupping Therapy on oxidative stress and antioxidant capacity of the body.The healthy volunteers will receive wet cupping application and their initial venous blood samples and samples after the treatment will be evaluated for oxidative stress.', 'detailedDescription': 'Among the healthy individuals who applied for Wet Cupping Therapy (WCT) to Traditional and Complementary Therapies center in Karabuk Medical Faculty Education and Research Hospital for general wellbeing 24 volunteers were enrolled in the study. They will receive three concecutive WCT application in one month interval.Their venous blood samples obtained initially and after the completion of the three concecutive applications, will be evaluted in terms of Reactive Oxygen species and Antioxidant capacity.Additionally samples from the cupping blood during the first and the third WCT application will also be obtained and evaluated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy male adults\n\nMust apply Traditional and complemantary medicine center for general well being.\n\nExclusion Criteria:\n\nAny chronic disorder\n\nAntiagregant drug usage\n\nBleeding disorders\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03503903', 'briefTitle': 'Efficacy of Wet Cupping on Reactive Oxygen Species and Antioxidants', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Efficacy of Wet Cupping on Reactive Oxygen Species and Antioxidant Capacity:A Self-controlled Interventional Study', 'orgStudyIdInfo': {'id': 'KBU-BAP-17/1-KA-070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wet Cupping', 'description': 'One armed self-controlled study. Individuals in this arm will receive three concecutive WCT application', 'interventionNames': ['Procedure: Wet Cupping']}], 'interventions': [{'name': 'Wet Cupping', 'type': 'PROCEDURE', 'description': 'CT was applied using plastic disposable vacuum cups on the back in the 5 areas of C7 cervical spine (DU14 acupoint), T2-4 lateral spine bilaterally (BL41-42 acupoint) and T6-8 lateral spine bilaterally (BL44-46), which are the recommended sites for headache (12). The cupping technique procedure was conducted in five phases:Primary suction,Area disinfection,Scarification,Secondary suction and bloodletting,Removing and dressing.', 'armGroupLabels': ['Wet Cupping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78070', 'city': 'Karabük', 'state': 'Karabük Province', 'country': 'Turkey (Türkiye)', 'facility': 'Karabuk University Karabuk Research and Education hospital', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}], 'overallOfficials': [{'name': 'SULEYMAN ERSOY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karabuk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asist.Prof. Department of Family Medicine', 'investigatorFullName': 'SULEYMAN ERSOY', 'investigatorAffiliation': 'Karabuk University'}}}}