Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-26 @ 3:50 PM
Study NCT ID:
NCT03492892
Status:
COMPLETED
Last Update Posted:
2018-04-13
First Post:
2018-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'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': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-11', 'studyFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2018-04-09', 'lastUpdatePostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 hour ambulatory blood pressure', 'timeFrame': 'up to week 6'}], 'secondaryOutcomes': [{'measure': 'targeted plasma metabolome', 'timeFrame': 'up to week 6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture', 'hypertension', 'targeted metabolome', 'pilot clinical trial'], 'conditions': ['Hypertension,Essential']}, 'descriptionModule': {'briefSummary': 'To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.', 'detailedDescription': 'Acupuncture has been widely used for blood pressure management. Its effect on the cardiovascular-related targeted metabolome is still unknown. This pilot study aimed to assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged between 45 and 75 years;\n* were diagnosed as stage I hypertension in the first visit, or used to be diagnosed with stage I hypertension in recent 1 year, but without any medication history;\n* without neurological, other cardiovascular, hepatic and renal disease, and other visceral diseases;\n* the basal metabolism rate of a patient, which was measured by the retrospective dietary questionnaire at baseline, should be approximately 1:1.4;\n* didn't administer any drugs or herbs in at 15 days before the start of the study;\n* didn't participate in any study other than this;\n* agreed to cooperate with researchers in all research procedures after they were introduced this study; and\n* provided with written informed consent.\n\nExclusion Criteria:\n\n* age≤45 or age≥75;\n* with hypertension which was secondary to other diseases, such as renal vascular disease, Cushing's syndrome, hyperadrenocorticism and drug-induced hypertension;\n* had complicated cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system and other severe primary diseases and failed to effectively control in clinic;\n* accompanied by epilepsy, sleep apnea, hypopnea syndrome, etc.;\n* with psychiatric symptoms such as severe depression or anxiety (SAS≥70, or SDS≥72);\n* pregnant or lactating woman, or woman of reproductive age who was intended to conceive in recent 1 year;\n* with abnormality in laboratory test of blood biochemistry, or with contagious risks, such as HIV virus carrier, or patient with positive Hepatitis B Virus (HBV) superficial antigen;\n* with malignant tumor or other severe consuming diseases, or patients with infections or bleeding disorders;\n* alcoholics or drug abusers, or vegetarians;\n* used to suffer from acute diseases in recent 2 weeks, such as high fever, or gastritis;\n* used to administer any drug that may potentially impaired renal or hepatic function;\n* with cardiovascular disease that had been treated with acupuncture within recent three months; or\n* undergoing other clinical trials."}, 'identificationModule': {'nctId': 'NCT03492892', 'briefTitle': 'Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives', 'orgStudyIdInfo': {'id': '2012KL-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Use real acupuncture treatment for blood pressure management in patients with hypertension', 'interventionNames': ['Device: Acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Acupuncture', 'description': 'Use non-acupoint as the stimulating site in acupuncture for the treatment of hypertension', 'interventionNames': ['Device: Sham Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'DEVICE', 'description': 'Stimulate acupoint with filiform needles to restore the healthy condition of patients', 'armGroupLabels': ['Acupuncture']}, {'name': 'Sham Acupuncture', 'type': 'DEVICE', 'description': 'Stimulate non-acupoint with filiform needles to treat the condition of patients', 'armGroupLabels': ['Sham Acupuncture']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fan-rong Liang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chengdu University of Traditional Chinese Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Patient Data will be shared upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}