Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-27 @ 6:49 PM
Study NCT ID:
NCT01975168
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect Evaluation of Laser Acupuncture in Obesity
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-11-01', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'waist circumference', 'timeFrame': '12 weeks'}, {'measure': 'hip circumference', 'timeFrame': '12 weeks'}, {'measure': 'body fat', 'timeFrame': '12 weeks'}, {'measure': 'blood pressure', 'timeFrame': '12 weeks'}, {'measure': 'heart rate', 'timeFrame': '12 weeks'}], 'primaryOutcomes': [{'measure': 'body composition', 'timeFrame': '12 weeks', 'description': 'body weight'}], 'secondaryOutcomes': [{'measure': 'body mass index', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['laser acupuncture', 'obesity'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '12580844', 'type': 'BACKGROUND', 'citation': 'Wozniak P, Stachowiak G, Pieta-Dolinska A, Oszukowski P. Laser acupuncture and low-calorie diet during visceral obesity therapy after menopause. Acta Obstet Gynecol Scand. 2003 Jan;82(1):69-73. doi: 10.1034/j.1600-0412.2003.820113.x.'}]}, 'descriptionModule': {'briefSummary': 'A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2 groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2 receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds every time, 3 times per week. The measurements of outcomes are performed in the beginning, weekly during treatment, and monthly after treatment for 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index over 25 kg/m2 or Waist girth over 80cm in female, waist girth over 90cm in male\n\nExclusion Criteria:\n\n* Pathmakers user\n* Epilepsy history\n* Pregnancy\n* Immuno-inhibiting agents user\n* Malignancy\n* Skin contacted disease\n* Weight controlled agents user during trial period\n* Eating disorder'}, 'identificationModule': {'nctId': 'NCT01975168', 'briefTitle': 'The Effect Evaluation of Laser Acupuncture in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'The Effect Evaluation of Laser Acupuncture in Obesity', 'orgStudyIdInfo': {'id': 'KMUH-LAAC-OB-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks', 'interventionNames': ['Device: Handylaser Trion laser acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group 2', 'description': 'arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks', 'interventionNames': ['Device: Handylaser Trion laser acupuncture']}], 'interventions': [{'name': 'Handylaser Trion laser acupuncture', 'type': 'DEVICE', 'otherNames': ['Handylaser Trion'], 'description': 'intervention interval is 3 times per week for 12 weeks', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Cheng-Che Lin', 'role': 'CONTACT', 'email': 'abcmacoto@gmail.com', 'phone': '+8863121101', 'phoneExt': '6422'}, {'name': 'Chen-Cheng Yang', 'role': 'CONTACT', 'email': 'cheng10042001@yahoo.com.tw', 'phone': '+886929919132'}, {'name': 'Chen-Cheng Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese Medicine Department Clinic, Kaohsiung Medical University', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Cheng-Che Lin, MD', 'role': 'CONTACT', 'email': 'abcmacoto@gmail.com', 'phone': '+8863121101', 'phoneExt': '6422'}, {'name': 'Chen-Cheng Yang, MD', 'role': 'CONTACT', 'email': 'cheng10042001@yahoo.com.tw', 'phone': '+886929919132'}], 'overallOfficials': [{'name': 'Cheng-Che Lin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Doctor of Chinese Medicine Department, Kaohsiung Medical University Hospital'}, {'name': 'Hung-Yi Chuang, ScD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Public Health, College of Health Sciences, Kaohsiung Medical University'}, {'name': 'Chen-Cheng Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Family Medicine Department, Kaohsiung Medical University Hospital and Kaohsiung Municipal Ta-Tung Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Chinese Medicine Department', 'investigatorFullName': 'Cheng-Che Lin', 'investigatorAffiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}}}}