Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT00969267
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2009-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Auricular Point Stimulation on Obese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-28', 'studyFirstSubmitDate': '2009-08-31', 'studyFirstSubmitQcDate': '2009-08-31', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% reducting of body mass index (BMI)', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ear acupuncture', 'obese', 'obese women', 'women'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '19445642', 'type': 'BACKGROUND', 'citation': 'Hsu CH, Wang CJ, Hwang KC, Lee TY, Chou P, Chang HH. The effect of auricular acupuncture in obese women: a randomized controlled trial. J Womens Health (Larchmt). 2009 Jun;18(6):813-8. doi: 10.1089/jwh.2008.1005.'}, {'pmid': '15953937', 'type': 'BACKGROUND', 'citation': 'Hsu CH, Hwang KC, Chao CL, Lin JG, Kao ST, Chou P. Effects of electroacupuncture in reducing weight and waist circumference in obese women: a randomized crossover trial. Int J Obes (Lond). 2005 Nov;29(11):1379-84. doi: 10.1038/sj.ijo.0802997.'}, {'pmid': '18468736', 'type': 'BACKGROUND', 'citation': 'Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine whether the ear acupoint stimulation is effective on obese women.', 'detailedDescription': '% change body weight, BMI, lipid profile, glucose and obese hormone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 16-65 years women\n* BMI\\>27 kg/mm\n* Signed informed consent\n\nExclusion Criteria:\n\n* Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.\n* Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.\n* Allergy and Immunology disease.\n* High aminotransferases ( Alanine, Aspartate \\> 80 IU/L) or high serum creatinine (\\> 2.5 mg/dL)\n* Pregnant or lactating women.\n* Childbirth within 6 months.\n* Stroke or otherwise unable to exercise\n* Management for weight control within 3 months.\n* Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.\n* Endocrine disease'}, 'identificationModule': {'nctId': 'NCT00969267', 'briefTitle': 'The Effect of Auricular Point Stimulation on Obese Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei City Hospital'}, 'officialTitle': 'The Effect of Auricular Point Stimulation on Obese Women: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '98001-62-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stimulation A', 'description': 'with needle A stimulation', 'interventionNames': ['Other: ear-acupuncture A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stimulation B', 'description': 'with stimulation', 'interventionNames': ['Other: stimulation B']}, {'type': 'SHAM_COMPARATOR', 'label': 'Stimulation C', 'description': 'without needle', 'interventionNames': ['Other: stimulation C']}], 'interventions': [{'name': 'ear-acupuncture A', 'type': 'OTHER', 'otherNames': ['ear acupuncture needle'], 'description': 'with needle stimulation', 'armGroupLabels': ['Stimulation A']}, {'name': 'stimulation B', 'type': 'OTHER', 'otherNames': ['ear acupuncture bread'], 'description': 'with bread stimulation on ear acupuncture point', 'armGroupLabels': ['Stimulation B']}, {'name': 'stimulation C', 'type': 'OTHER', 'otherNames': ['placebo needle'], 'description': 'without needle stimulation', 'armGroupLabels': ['Stimulation C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Branch of Chinese Medicine, Taipei City Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chung-Hua Hsu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insitute of Traditional Medicine, National Yang Ming University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei City Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice superintendent', 'investigatorFullName': 'Chung-Hua Hsu', 'investigatorAffiliation': 'Taipei City Hospital'}}}}