Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 4:25 PM
Study NCT ID:
NCT03805035
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2019-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}, {'id': 'D006633', 'term': 'Histamine Antagonists'}, {'id': 'D002744', 'term': 'Chlorpheniramine'}, {'id': 'C018904', 'term': 'dexchlorpheniramine'}, {'id': 'D013607', 'term': 'Tablets'}, {'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'}, {'id': 'D018494', 'term': 'Histamine Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D010632', 'term': 'Pheniramine'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2019-01-08', 'studyFirstSubmitQcDate': '2019-01-13', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES)', 'timeFrame': 'baseline and 10min after treatment', 'description': 'Transcutaneous electrical stimulation (TCES) is used as a method of inducing pain in the study. The procedure is to attach two electrode patches on the inside of the upper arm of the subject and then connect the electric stimulator. The current intensity will gradually increase from 0 mA, and each time increase 0.5amps until the subject feels pain in the visual analogy. Transcutaneous electrical stimulation (TCES) will be stopped at the visual analog scale of 5 (that means the moderate pain). The current intensity will be compared within and between each group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electroacupuncture (EA)', 'Antihistamine', 'Pain'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '1351926', 'type': 'BACKGROUND', 'citation': 'Traiffort E, Pollard H, Moreau J, Ruat M, Schwartz JC, Martinez-Mir MI, Palacios JM. Pharmacological characterization and autoradiographic localization of histamine H2 receptors in human brain identified with [125I]iodoaminopotentidine. J Neurochem. 1992 Jul;59(1):290-9. doi: 10.1111/j.1471-4159.1992.tb08903.x.'}, {'pmid': '14698480', 'type': 'BACKGROUND', 'citation': 'Zhang WT, Jin Z, Luo F, Zhang L, Zeng YW, Han JS. Evidence from brain imaging with fMRI supporting functional specificity of acupoints in humans. Neurosci Lett. 2004 Jan 2;354(1):50-3. doi: 10.1016/j.neulet.2003.09.080.'}, {'pmid': '36081814', 'type': 'DERIVED', 'citation': 'Lee YC, Tu CH, Chung HY, Luo ST, Chu YT, MacDonald IJ, Kotha P, Huang CC, Lane HY, Lin JG, Chen YH. Antihistamine promotes electroacupuncture analgesia in healthy human subjects: A pilot study. J Tradit Complement Med. 2022 Apr 21;12(5):511-517. doi: 10.1016/j.jtcme.2022.04.003. eCollection 2022 Sep.'}]}, 'descriptionModule': {'briefSummary': 'Acupuncture has been used in traditional Chinese medicine for around 3,000 years and is increasingly practiced worldwide. The effects of acupuncture in chronic pain have been investigated in many clinical trials. Histamine H1 receptor antagonists are commonly used for treating allergy. Recently, investigators found that histamine H1 receptor antagonists at relatively low doses facilitate EA analgesia in the acetic acid-induced abdominal writhing test. Investigators aim to further explore whether histamine H1 receptor antagonists also facilitate EA analgesia in humans.The aims of the proposed studies are to: Conduct a clinical trial to demonstrate that H1 receptor antagonists at relatively low doses facilitate EA analgesia in healthy volunteers. This study will recruit 40 healthy normal subjects (aged between 20 and 30 years) who will be randomly assigned to one of four groups: (1) Sham acupuncture (Shallow needling without electrical stimulation) at ST36 and GB34; (2) EA at ST36 and GB34; (3) EA at ST36 and GB34 plus low-dose chlorpheniramine (2 mg); (4) EA at ST36 and GB34 plus regular-dose chlorpheniramine (4 mg). The primary endpoint will be the pain threshold. It is expected that the completion of this proposed study will enhance our knowledge as to how acupuncture analgesia can be promoted by antihistamine drugs given at a low dose and help to define its application for clinical use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. . Age: 20 to 30 years of age.\n2. . Agrees to undergo a comprehensive medical history and physical examination.\n3. . No history of analgesic, sedative, dietary/appetite medication intake for more than 3 weeks prior to enrolment.\n\nExclusion Criteria:\n\n1. . An ongoing medical condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being (e.g., hypertension, diabetes mellitus, or epilepsy).\n2. . A compromised skin barrier (e.g., skin disease, allergy) that would interfere with the conduct of the EA procedure and assessments of the study.\n3. . An implant such as a pacemaker, defibrillator, or electronic medical equipment.\n4. . Pregnancy, or planning for pregnancy."}, 'identificationModule': {'nctId': 'NCT03805035', 'briefTitle': 'Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research', 'orgStudyIdInfo': {'id': 'CMUH107-REC3-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'sham EA group', 'description': 'Minimal needling at ST36 and GB34 (n=10)', 'interventionNames': ['Device: acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'true EA group', 'description': 'EA at ST36 and GB34 (n=10)', 'interventionNames': ['Device: electroacupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EA+antihistamine(low dose) group', 'description': 'EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10)', 'interventionNames': ['Device: electroacupuncture', 'Drug: antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EA+antihistamine(high dose) group', 'description': 'EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10)', 'interventionNames': ['Device: electroacupuncture', 'Drug: antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)']}], 'interventions': [{'name': 'electroacupuncture', 'type': 'DEVICE', 'description': 'Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)', 'armGroupLabels': ['EA+antihistamine(high dose) group', 'EA+antihistamine(low dose) group', 'true EA group']}, {'name': 'antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)', 'type': 'DRUG', 'otherNames': ['chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab)'], 'description': 'Group 3 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)', 'armGroupLabels': ['EA+antihistamine(low dose) group']}, {'name': 'antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)', 'type': 'DRUG', 'otherNames': ['chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs)'], 'description': 'Group 4 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)', 'armGroupLabels': ['EA+antihistamine(high dose) group']}, {'name': 'acupuncture', 'type': 'DEVICE', 'otherNames': ['shallow needling'], 'description': 'Minimal needling at ST36 and GB34', 'armGroupLabels': ['sham EA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Yi-Hung Chen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Graduate Institute of Acupuncture Science, China Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}