Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT01665105
Status:
COMPLETED
Last Update Posted:
2013-07-12
First Post:
2012-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Effect of Electroacupuncture at Both Zusanli and at Both Yanglingquan Acupoints on Cardiovascular Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-11', 'studyFirstSubmitDate': '2012-07-20', 'studyFirstSubmitQcDate': '2012-08-13', 'lastUpdatePostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'From pulse wave, pulse rate variability and skin blood flow to measure cardiovascular activities with electroacupuncture at Zusanli and at Yanglingquan.', 'timeFrame': 'each period was 20 min in duration. The parameters of pulse wave, 5-min pulse rate variability were recorded at the end of each period.', 'description': 'Each session was divided into three periods of before electroacupuncture, electroacupuncture, and post electroacupuncture. Each period was 20 min in duration. During each period, the final 5 min of the period was pulse rate variability recordings of left hand by ANSWatch(TS-0411 model). This data were storage as primary outcomes and analyzed in a personal computer.'}], 'secondaryOutcomes': [{'measure': 'From skin blood flow and skin temperature to measure cardiovascular activities with electroacupuncture at Zusanli and at Yanglingquan.', 'timeFrame': 'each period was 20 min in duration. The parameters of skin blood flow and skin temperature were recorded at the end of each period.', 'description': "Each session was divided into three periods of before electroacupuncture, electroacupuncture, and post electroacupuncture. Each period was 20 min in duration. During each period, the ahead 15 min of the period was the skin blood flow and skin temperature recordings at Hoku's and Zhongzhu's region of right hand by Laser doppler blood flow monitor (Moor instruments DRT4 model). This data were storage as seconrdary outcomes and analyzed in a personal computer."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulse Rate Variability', 'Skin Blood Flow', 'Skin Temperature', 'Electroacupuncture', 'Zusanli', 'Yanglingquan'], 'conditions': ['Reaction of Autonomic Nervous System', 'Reaction of Acupuncture', 'Reaction of Blood Circulation']}, 'descriptionModule': {'briefSummary': 'The purpose of this present study was to investigate the effect of electroacupuncture at both Zusanli and at both Yanglingquan acupoints on autonomic nerve modulating cardiovascular activity, and skin blood flow and skin temperature. The investigators use pulse rate variability to investigate autonomic nerve modulates cardiovascular function, and using distant skin blood flow and skin temperature recordings to investigate the relationship between the same names meridian of hand and foot.', 'detailedDescription': "A total of 24 adult healthy volunteer were studied, they received the three sessions of sham electroacupuncture, electroacupuncture at Zusanli and electroacupuncture at Yanglingquan, respectively. Each session was divided into three periods of before electroacupuncture, electroacupuncture, and post electroacupuncture. Each period was 20 min in duration. The ahead 15 min of the period was the skin blood flow and skin temperature recordings at Hoku's and Zhongzhu's region of right hand; the final 5 min of the period was pulse rate variability recordings of left hand. The data was storage and analysis in a personal computer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. healthy volunteers without without cardiac disease, taking medications, smoking\n2. before experiment, abstaining from caffeine, alcohol for 8 hours.\n3. age between 20-40.\n\nExclusion Criteria:\n\n1. volunteers with cardiac disease, taking medications, smoking\n2. age greater than 40 or less than 20.'}, 'identificationModule': {'nctId': 'NCT01665105', 'briefTitle': 'Study on the Effect of Electroacupuncture at Both Zusanli and at Both Yanglingquan Acupoints on Cardiovascular Activity', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Study on the Effect of Electroacupuncture at Both Zusanli and at Both Yanglingquan Acupoints on Autonomic Nerve Modulating Cardiovascular Activity , and Skin Blood Flow and Skin Temperature', 'orgStudyIdInfo': {'id': 'DMR101-IRB2-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zusanli Group', 'description': "electroacupuncture at both Zusanli on the leg, and record simultaneously the pulse rate variability as well as take the skin blood flow and skin temperature recordings at Hoku's and Zhongzhu's region of right hand.", 'interventionNames': ['Device: acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Yanlingquan Group', 'description': "electroacupuncture at both Yanglingquan on the leg, and record simultaneously the pulse rate variability as well as take the skin blood flow and skin temperature recordings at Hoku's and Zhongzhu's region of right hand.", 'interventionNames': ['Device: acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group', 'description': "acupuncture without electrical stimulation at non-acupoint on the leg, and record simultaneously pulse rate variability as well as take the skin blood flow and skin temperature recordings at Hoku's and Zhongzhu's region of right hand.", 'interventionNames': ['Device: acupuncture']}], 'interventions': [{'name': 'acupuncture', 'type': 'DEVICE', 'description': 'electroacupuncture at at Zusanli, electroacupuncture at Yanglingquan, and acupuncture at non-acupoint.', 'armGroupLabels': ['Sham Group', 'Yanlingquan Group', 'Zusanli Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Ching-Liang Hsieh, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}