Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 2:40 AM
Study NCT ID:
NCT01225133
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2010-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC)', 'timeFrame': 'week 12'}], 'secondaryOutcomes': [{'measure': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales', 'timeFrame': 'month 6'}, {'measure': 'SF-36-questionnaire', 'timeFrame': 'week 12'}, {'measure': 'POMS-questionnaire', 'timeFrame': 'week 12'}, {'measure': 'Visual Analogue Scales: Pain', 'timeFrame': 'week 12'}, {'measure': 'Visual Analogue Scales: Sleep', 'timeFrame': 'week 12'}, {'measure': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales', 'timeFrame': 'month 12'}, {'measure': 'SF-36-questionnaire', 'timeFrame': 'month 6'}, {'measure': 'SF-36-questionnaire', 'timeFrame': 'month 12'}, {'measure': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales', 'timeFrame': 'week 12'}, {'measure': 'POMS-questionnaire', 'timeFrame': 'month 6'}, {'measure': 'POMS-questionnaire', 'timeFrame': 'month 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoarthritis, Osteoarthrosis, Arthritis, Arthrosis'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '29426006', 'type': 'DERIVED', 'citation': 'Kessler CS, Dhiman KS, Kumar A, Ostermann T, Gupta S, Morandi A, Mittwede M, Stapelfeldt E, Spoo M, Icke K, Michalsen A, Witt CM. Effectiveness of an Ayurveda treatment approach in knee osteoarthritis - a randomized controlled trial. Osteoarthritis Cartilage. 2018 May;26(5):620-630. doi: 10.1016/j.joca.2018.01.022. Epub 2018 Feb 7.'}, {'pmid': '23701973', 'type': 'DERIVED', 'citation': 'Witt CM, Michalsen A, Roll S, Morandi A, Gupta S, Rosenberg M, Kronpass L, Stapelfeldt E, Hissar S, Muller M, Kessler C. Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee--study protocol for a randomized controlled trial. Trials. 2013 May 23;14:149. doi: 10.1186/1745-6215-14-149.'}], 'seeAlsoLinks': [{'url': 'http://www.charite.de', 'label': 'Charite Medical University'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of a complex āyurvedic diagnosis and treatment compared to conventional standard care in patients with OA of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients,\n* Age 40-70 years,\n* Prediagnosed, confirmed and documented diagnosis of OA of the knee. Diagnosis performed by a medical specialist (orthopedic surgeon, surgeon, radiologist) according to the American College of Rheumatology criteria,\n* Documented radiologic changes of the knee-joint Kellgren-Lawrence criteria \\> or = grade 2 in conventional X-ray or MRI-scan,\n* Mean average pain intensity of 40 or more on two 100 mm visual analogue scales in the 7 days before baseline assessment,\n* Written informed consent.\n\nExclusion Criteria:\n\n* Pain in the knee caused by oCongenital dysplasia of the affected knee oRheumatoid arthritis oAutoimmune diseases oMalignancies oStatus post Knee surgery oStatus post Arthroscopy\n* Administration of chondroprotective drugs in the preceding 3 months,\n* Intra-articular injection into the affected knee-joint during the preceding 3 months,\n* Beginning of a systemic medication with corticosteroids within the preceding three months,\n* Beginning of any new treatment for OA during the previous 4 weeks (with the exception of analgesic treatment with Paracetamol or NSAIDs),\n* Pregnancy or breastfeeding,\n* Acute mental disorders,\n* Serious acute organic diseases,\n* Serious chronic co-morbidity,\n* Obesity WHO-grade II/III\n* Blood coagulation disorders,\n* Coagulation-inhibiting medication other than Aspirin and Clopidogrel,\n* Invasive measures performed at the affected joint during the previous 12 weeks or planned within the following 12 month,\n* In the process of applying for pension or disability benefits,\n* Simultaneous participation in any other clinical trial,\n* Participation in a clinical trial during the 6 month before inclusion into this trial,\n* Missing of the written informed consent form.'}, 'identificationModule': {'nctId': 'NCT01225133', 'acronym': 'CARAKA', 'briefTitle': 'Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'The CARAKA-Trial: Complex Āyurvedic Treatment in Osteoarthritis of the Knee Against Standard Care.A Multicentre, Randomized, Controlled Clinical Trial Based on Traditional Āyurveda-Diagnosis.', 'orgStudyIdInfo': {'id': 'CARAKA-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Complex Ayurvedic Treatment', 'description': 'In the Āyurveda arm treatment will be individualized according to the Āyurveda diagnosis and include manual treatments, massages, dietary advice, specific consideration of selected food items, nutritional supplements, āyurvedic lifestyle and yoga posture advice and daily self-applied knee massage.', 'interventionNames': ['Other: Complex Ayurvedic Treatment', 'Other: Conventional Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Care', 'description': 'Patients in the conventional standard care group will receive conventional standard care for OA of the Knee which includes self care advice, pain medication and intensified physiotherapy and follows the current international guidelines for OA of the knee.', 'interventionNames': ['Other: Complex Ayurvedic Treatment', 'Other: Conventional Care']}], 'interventions': [{'name': 'Complex Ayurvedic Treatment', 'type': 'OTHER', 'description': 'In the Āyurveda group treatment will be individualized according to the Āyurveda diagnosis and include manual treatments, massages, dietary advice, specific consideration of selected food items, nutritional supplements, āyurvedic lifestyle and yoga posture advice and daily self-applied knee massage.', 'armGroupLabels': ['Complex Ayurvedic Treatment', 'Conventional Care']}, {'name': 'Conventional Care', 'type': 'OTHER', 'description': 'Patients in the conventional standard care group will receive conventional standard care for OA of the Knee which includes self care advice, pain medication and intensified physiotherapy and follows the current international guidelines for OA of the knee.', 'armGroupLabels': ['Complex Ayurvedic Treatment', 'Conventional Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10119', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité Medical University Cooperation Center Sonne und Mond', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14109', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Immanuel Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Michalsen, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité Medical University Berlin'}, {'name': 'Claudia M Witt, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité University Medical Center Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health & Family Welfare, India', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Andreas Michalsen', 'investigatorFullName': 'Andreas Michalsen', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}