Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT03600220
Status:
UNKNOWN
Last Update Posted:
2018-07-26
First Post:
2018-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Effect of Combined Chinese and Western Treatment on Home Medical Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': 'change from Baseline Systolic Blood Pressure at 3 months', 'description': 'measure blood pressure after the treatment compare the initial blood pressure'}], 'secondaryOutcomes': [{'measure': 'Traditional Chinese Medicine constitution', 'timeFrame': 'use the questionnaire at Baseline, 1.5 month, and three month later', 'description': 'use The Constitution in Chinese Medicine Questionnaire'}, {'measure': 'heart rate variability', 'timeFrame': "use ANS watch to monitor patient's condition at Baseline, 1.5 month, and three month later", 'description': "use autonomic nervous system (ANS) watch to monitor patient's heart rate variability, Low Frequency/High Frequency ratio"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture, hypertension, elderly, home health care'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'combine antihypertensive drugs and acupuncture to isolated systolic hypertension elderly patients at home', 'detailedDescription': 'The investigators would like to compare the effectiveness of acupuncture and drug therapy on blood pressure.\n\nThe investigators chose acupuncture point according the Traditional Chinese Medicine theory, besides, each patient was using 1-3 antihypertensive drug of a heterogeneous pharmacological group ranging from angiotensin-converting enzyme inhibitor (ACE inhibitor), diuretics, and beta blockers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patient with isolated blood pressure diagnosis by physicians and BP \\>140/\\<90 mmHg\n2. patient took the drug to control blood pressure for more than one year\n3. age\\>65 years old\n4. Willing to participate in this study\n\nExclusion Criteria:\n\n1. Suspected acute stroke\n2. chest pain or dyspnea\n3. ingestion of short-acting antihypertensive medication within 2 h prior to the beginning of the study\n4. body temperature \\>37.5∘C(99.5∘F)'}, 'identificationModule': {'nctId': 'NCT03600220', 'briefTitle': 'Exploring the Effect of Combined Chinese and Western Treatment on Home Medical Care', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei City Hospital'}, 'officialTitle': 'Effectiveness of Combining Antihypertensive Drugs and Acupuncture on Isolated Systolic Hypertension of Elderly Patients at Home', 'orgStudyIdInfo': {'id': 'TCHIRB-10703120-E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'drug use', 'description': 'routine drug use, each patient was using 1-3 antihypertensive drug of a heterogeneous pharmacological group ranging from ACE inhibitors, diuretics, and beta blockers'}, {'type': 'EXPERIMENTAL', 'label': 'drug combine acupuncture', 'description': 'routine drug use combine acupuncture twice a week for 3 months', 'interventionNames': ['Other: acupuncture']}], 'interventions': [{'name': 'acupuncture', 'type': 'OTHER', 'otherNames': ['drug'], 'description': 'antihypertension drug, acupuncture twice a week for 3 months', 'armGroupLabels': ['drug combine acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '104', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei City Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Kuei-Yu Huang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taipei City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}