Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 7:07 PM
Study NCT ID:
NCT02044432
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2014-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Patients With Chronic Osteoarthritis With Ginger Kidney Compress - a Randomized, Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sum Score of "Short Arthritis Assessment Scale" questionnaire', 'timeFrame': 'After 5 weeks of treatment and 5 weeks follow up'}, {'measure': 'Parameters of a warmth questionnaire', 'timeFrame': 'After 5 weeks of treatment and 5 weeks follow up'}, {'measure': 'Range of knee movement', 'timeFrame': 'After 5 weeks of treatment and 5 weeks follow up'}, {'measure': 'Thermography (body heat distribution)', 'timeFrame': 'After 5 weeks of treatment and 5 weeks follow up'}], 'primaryOutcomes': [{'measure': 'Total Sum Score (WOMAC)', 'timeFrame': 'Change from baseline at 5 weeks of treatment and 5 weeks follow up'}], 'secondaryOutcomes': [{'measure': 'Change in medication', 'timeFrame': 'After 5 weeks of treatment and 5 weeks follow up'}]}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that by a 5-week treatment with ginger kidney compresses at least 2 of 3 main symptoms of the WOMAC (pain, stiffness, functionality) will be reduced at least 30% at the time of the post-measurement (after 5 weeks of therapy) in comparison to the respective control group (waitlist).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic osteoarthritis, mainly osteoarthritis of the knee\n* osteoarthritis symptoms for at least six months\n* written consent to participate in the study\n* Age: 30 years and more\n\nExclusion Criteria:\n\n* Rheumatoid Arthritis\n* Fibromyalgia\n* Oncological or other serious diseases\n* Use of corticosteroids\n* Nephropathy\n* Non-intact skin conditions in the area of application\n* Hypersensitivity / allergy to ginger\n* Simultaneous participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT02044432', 'acronym': 'OST_02', 'briefTitle': 'Treatment of Patients With Chronic Osteoarthritis With Ginger Kidney Compress - a Randomized, Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'ARCIM Institute Academic Research in Complementary and Integrative Medicine'}, 'officialTitle': 'Treatment of Patients With Chronic Osteoarthritis (Gonarthrosis) With Ginger Kidney Compress - a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'OST_02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ginger compress', 'interventionNames': ['Other: ginger compress']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list'}], 'interventions': [{'name': 'ginger compress', 'type': 'OTHER', 'description': 'Kidney ginger compress', 'armGroupLabels': ['Ginger compress']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ARCIM Institute Academic Research in Complementary and Integrative Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Jan Vagedes MD', 'investigatorFullName': 'Dr. Jan Vagedes', 'investigatorAffiliation': 'ARCIM Institute Academic Research in Complementary and Integrative Medicine'}}}}