Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-25 @ 2:45 PM
Study NCT ID:
NCT00065650
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2003-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of Vedic Medicine for Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2004-01'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2003-07-30', 'studyFirstSubmitQcDate': '2003-07-30', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1C', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Fasting Glucose', 'timeFrame': '3 and 6 months'}, {'measure': 'Lipids', 'timeFrame': '3 and 6 months'}]}, 'conditionsModule': {'keywords': ['Diabetes Mellitus Type 2', 'Vedic medicine', 'Ayurveda', 'Transcendental Meditation'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Elder C. Application of the cooperative health care clinic model for the delivery of complementary/ alternative care. The Permanente Journal. Winter 2003; 7(1):55-60.'}, {'type': 'BACKGROUND', 'citation': 'Elder C. Complementary and Alternative Medicine Symposium: Integrating CAM into clinical practice: The KP northwest story. The Permanente Journal, Fall 2002, 6(4):57-59'}, {'pmid': '17017752', 'type': 'RESULT', 'citation': 'Elder C, Aickin M, Bauer V, Cairns J, Vuckovic N. Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes. Altern Ther Health Med. 2006 Sep-Oct;12(5):24-30.'}], 'seeAlsoLinks': [{'url': 'http://www.kpchr.org/public/default.asp', 'label': 'Kaiser Permanente Center for Health Research External Site'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasibility and effectiveness of a multimodality Vedic Medicine treatment protocol for the management of newly diagnosed type 2 diabetes.', 'detailedDescription': 'Maharishi Vedic Medicine (MVM) represents a synthesis of Vedic sciences, including Ayur-Veda, into a single, comprehensive, natural approach to health care. The objectives of this phase II pilot trial are to determine the feasibility, acceptability, and safety of implementing a multi-modality MVM intervention for newly diagnosed type 2 diabetics, and to measure the impact of such a protocol on overall glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Kaiser Permanente members\n* Newly diagnosed type 2 Diabetes\n* Baseline glycosylated hemoglobin level of 6.0-7.9.\n\nExclusion criteria:\n\n* Pregnancy or nursing mother\n* Currently taking warfarin\n* Diagnosis of psychotic disorder or recent hospitalization for depression\n* Unable to comply with or attend treatment sessions'}, 'identificationModule': {'nctId': 'NCT00065650', 'briefTitle': 'Pilot Study of Vedic Medicine for Type 2 Diabetes', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'orgStudyIdInfo': {'id': 'R21AT001324-01', 'link': 'https://reporter.nih.gov/quickSearch/R21AT001324-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vedic Medicine', 'type': 'DRUG'}, {'name': 'Vedic Medicine', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kaiser Permanente Center for Health Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}