Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT05792358
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-25
First Post:
2023-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wet Cupping Therapy in Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2023-03-18', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BASFI', 'timeFrame': 'At 0 and 3 months', 'description': 'Change in the scores of The Bath Ankylosing Spondylitis Functional Index'}, {'measure': 'BASDAI', 'timeFrame': 'At 0 and 3 months', 'description': 'Change in the scores of The Bath Ankylosing Spondylitis Disease Activity Index'}, {'measure': 'VAS', 'timeFrame': 'At 0 and 3 months', 'description': 'Change in the scores of Visual Analogue Scale'}], 'secondaryOutcomes': [{'measure': 'Schober', 'timeFrame': 'At 0 and 3 months', 'description': 'Change in the scores of Modified Schober Test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankylosing Spondylitis', 'Wet cupping therapy', 'Basfi', 'Basdai', 'Vas'], 'conditions': ['Ankylosing Spondylitis']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of wet cupping therapy in patients with ankylosing spondylitis.Wet cupping therapy will be applied to half of the patients plus routine pharmaceutical treatment while the other half will receive only pharmaceutics', 'detailedDescription': 'In addition to the medical treatment, WCT will be applied once a month, 3 times (Day 0, 30, 60) to the intervention group whereas the control group will not receive any intervention. The BASFI, BASDAI, VAS and Schober test will be applied to both groups at 0 and 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nClinical diagnosis of ankylosing spondylitis 18-65 years of age Consent to participate\n\nExclusion Criteria:\n\nAny ongoing medical treatment other than NSAIDs Pregnancy At least one contraindication to WCT that was detected in subject's history or in the routine blood examinations prior to enrollment (Hgb \\<9.5; INR\\> 1.2; history of hemophobia, bleeding disorder, malignant disorder)."}, 'identificationModule': {'nctId': 'NCT05792358', 'briefTitle': 'Wet Cupping Therapy in Ankylosing Spondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Wet Cupping Therapy in Ankylosing Spondylitis: a Multicenter Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'SBU177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wet cupping arm', 'description': 'This arm is the interventiom group and will receive three consecutive sessions of wet cupping therapy once a month.', 'interventionNames': ['Procedure: wet cupping therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'This arm is the control group and will not receive any intervention other than the routine medications'}], 'interventions': [{'name': 'wet cupping therapy', 'type': 'PROCEDURE', 'description': 'wet cupping therapy will be applied to participants in this arm for three sessions once a month', 'armGroupLabels': ['Wet cupping arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karabük', 'country': 'Turkey (Türkiye)', 'facility': 'Karabuk University', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the complementary medicine department', 'investigatorFullName': 'SULEYMAN ERSOY', 'investigatorAffiliation': 'Karabuk University'}}}}