Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-28 @ 11:11 AM
Study NCT ID:
NCT04514068
Status:
UNKNOWN
Last Update Posted:
2020-08-14
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.
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'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of blood pressure.', 'timeFrame': 'up to 6 months', 'description': 'It is expected that both blood pressure and heart rate will be reduced during the electroacupuncture of P6 acupoint.'}, {'measure': 'Reduction of Heart Rate', 'timeFrame': 'up to 6 months', 'description': 'Heart Rate is also expected to be reduced with the stimulation of p6 acupoint.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled clinical trial with three parallel arms. This trial aims to evaluate the effectiveness of electroacupuncture on P6 acupoint for patients with hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients above 18 years old\n* Have not recently had any changes in anti-hypertensive medications\n* Have not recently been discharged from hospital/are stable\n* Is not having any acute infection.\n\nExclusion Criteria:\n\n* Trypanophobia\n* Below 18 years of age\n* Is currently having an acute infection\n* Is unstable or have been discharged recently from hospital\n* Changes made to anti-hypertensive medications'}, 'identificationModule': {'nctId': 'NCT04514068', 'acronym': 'EEP6', 'briefTitle': 'Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Ong Fujian Chinese Physician Hall'}, 'officialTitle': 'Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.', 'orgStudyIdInfo': {'id': 'OngFujianCPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unilateral electroacupuncture of p6 acupoint', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'Bilateral electroacupuncture of p6 acupoint', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham acupuncture of p6 acupoint', 'interventionNames': ['Procedure: Sham acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': 'In each session, acupuncture are applied unilaterally or bilaterally on P6 acupoint. Each acupuncture needle will be stimulated by transcutaneous electric device.', 'armGroupLabels': ['Bilateral electroacupuncture of p6 acupoint', 'Unilateral electroacupuncture of p6 acupoint']}, {'name': 'Sham acupuncture', 'type': 'PROCEDURE', 'description': 'Sham acupuncture', 'armGroupLabels': ['Sham acupuncture of p6 acupoint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '427513', 'city': 'Singapore', 'country': 'Singapore', 'contacts': [{'name': 'Lin Ho Wong, MB BCh BAO', 'role': 'CONTACT', 'phone': '82992667'}], 'facility': 'Ong Fujian Chinese Physician Hall', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Lin Ho Wong, MB BCh BAO', 'role': 'CONTACT', 'email': 'nate.wong90@live.com.sg', 'phone': '+6582992667'}], 'overallOfficials': [{'name': 'Lin Ho Wong, MB BCH BAO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ong Fujian Chinese Physician Hall'}, {'name': 'Pang Ong Wong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ong Fujian Chinese Physician Hall'}, {'name': 'Eng Soon Ong, Bachelor of TCM', 'role': 'STUDY_CHAIR', 'affiliation': 'Ong Fujian Chinese Physician Hall'}, {'name': 'Choo Keok Lim, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ong Fujian Chinese Physician Hall'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ong Fujian Chinese Physician Hall', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Lin Ho Wong', 'investigatorAffiliation': 'Ong Fujian Chinese Physician Hall'}}}}