Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05530512
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2022-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture Therapy and Hypertension
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': 'D015671', 'term': 'Electroacupuncture'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The pharmacologist who assays the plasma and serum is masked in the study.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'two by two factorial design for a 4 arm study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2022-08-27', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': 'through study completion, an average of 4.5 years', 'description': 'Blood pressure (systolic and diastolic) will be measured with an ambulatory blood pressure device every 20 min for 24 hours.'}], 'primaryOutcomes': [{'measure': 'Changes in sympathetic and parasympathetic nervous systems', 'timeFrame': 'through study completion, an average of 4.5 years', 'description': 'Heart rate variability and its component will be evaluated with EKG.'}], 'secondaryOutcomes': [{'measure': 'Change in biomarkers like cytokines', 'timeFrame': 'through study completion, an average of 4.5 years', 'description': 'Plasma will be measured for inflammatory markers with ELISA kits.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension, electroacupuncture'], 'conditions': ['Mild to Moderate Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1089/acu.2015.1106', 'label': 'clinical study'}, {'url': 'https://doi.org/10.3389/fcvm.2023.1140255', 'label': 'animal study'}]}, 'descriptionModule': {'briefSummary': 'Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will be either on or off hypertensive medications. The course last for 8 weeks and the frequency is once a week.', 'detailedDescription': 'Improvement in BP control rates would lead to one of the largest impacts in improving life expectancy and the quality of life for over 100 million people in the United States and 1 billion people worldwide with immediate and measurable results. In the United States, 80% of patients with HTN are treated, but BP is controlled in only half of these individuals, with control worsening with increasing age. The reasons for inadequate treatment and BP control are complex, but one reason for this therapeutic misalignment may be an incomplete understanding of the mechanisms underlying the development and progression of HTN. The aging process leads to dysfunction of the ANS, resulting in neuroendocrine abnormalities and chronic low-grade inflammation.\n\nThe investigators have previously shown that electroacupuncture (EA) at four targeted acupoints, can decrease sympathetic activity \\[sympathoinhibitory (SI)\\], approaching levels close to those present prior to onset of HTN and may address this unmet need in HTN management. The investigators are now testing and have preliminary evidence that EA at two additional acupoints (SP6-7) increases parasympathetic activation, thereby decreasing circulating and tissue inflammatory biomarkers \\[thus anti-inflammatory (AI)\\] and when combined with SI-EA can improve measures of vascular health including endothelial function and arterial stiffness in preclinical model with overall greater reduction in BP. Together these combined six acupoints, when simultaneously activated by EA may restore optimal autonomic control of the immune system and target an important mechanistic pathway not addressed by BP-lowering pharmacotherapy alone. To date, 39 participants have been enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects from 45 to 75 years of age\n2. Clinically diagnosed with mild to moderate hypertension and ON or OFF medication (Office SBP \\> 140 mmHg and \\< 160 mmHg Or ABPM average SBP \\> 130 mmHg and \\< 145 mmHg), and\n3. No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.\n\nExclusion Criteria:\n\n1. Subjects will be excluded if pregnant or nursing.\n2. Subjects will be excluded if they have coronary disease (by history or on ECG screening), conduction abnormalities on ECG consistent with left bundle branch block, cardiac arrhythmias associated with low blood pressure (\\<90 mmHg), peripheral vascular disease, orthopedic disease, diabetic neuropathy or severe hypertension (BP \\>170 mmHg systolic or \\>110 mmHg diastolic), or any other physical or psychological illness.\n3. Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.\n4. Inability our or unwillingness of individual to give written informed consent.'}, 'identificationModule': {'nctId': 'NCT05530512', 'briefTitle': 'Acupuncture Therapy and Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Neuroimmune Mechanisms Underlying Electroacupuncture Effect on Vascular Function', 'orgStudyIdInfo': {'id': '19992222'}, 'secondaryIdInfos': [{'id': 'R01AT011306', 'link': 'https://reporter.nih.gov/quickSearch/R01AT011306', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-inflammatory EA (AI-EA)', 'description': 'Anti-inflammatory electroacupuncture therapy', 'interventionNames': ['Other: electroacupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'Sympathoinhibitory EA (SI-EA)', 'description': 'sympatho-inhibitory electroacupuncture therapy', 'interventionNames': ['Other: electroacupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'Combined EA (cEA)', 'description': 'combination of SI-EA and AI-EA', 'interventionNames': ['Other: electroacupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'Control EA (Sham-EA)', 'description': 'Sham electroacupuncture', 'interventionNames': ['Other: electroacupuncture']}], 'interventions': [{'name': 'electroacupuncture', 'type': 'OTHER', 'otherNames': ['acupuncture'], 'description': 'acupuncture needling and stimulation are applied for 30 min', 'armGroupLabels': ['Anti-inflammatory EA (AI-EA)', 'Combined EA (cEA)', 'Control EA (Sham-EA)', 'Sympathoinhibitory EA (SI-EA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitchell Beasley, MD, PhD, MPH', 'role': 'CONTACT', 'email': 'beasleym@uci.edu', 'phone': '949-824-7000'}, {'name': 'Shaista Malik, PhD', 'role': 'CONTACT', 'email': 'smalik@hs.uci.edu', 'phone': '949-824-7000'}, {'name': 'LiFang Xie, PhD, LAc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shaista Malik, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stephanie Tjen-A-Looi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Susan Samueli Integrative Health Institute', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Herlinda Bergman, M.Sc.', 'role': 'CONTACT', 'phone': '714-456-7090'}], 'facility': 'University of California, Irvine, Health Sciences Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'Ashwini Erande', 'role': 'CONTACT', 'email': 'aerande@hs.uci.edu', 'phone': '7144567025'}], 'overallOfficials': [{'name': 'Shaista Malik', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shaista Malik', 'investigatorAffiliation': 'University of California, Irvine'}}}}