Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT05330403
Status:
COMPLETED
Last Update Posted:
2022-04-18
First Post:
2022-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Moxibustion-Induced Thermal Transport Effect Between The Heart And Lung Meridians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009071', 'term': 'Moxibustion'}], 'ancestors': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temperature change of relevant sites', 'timeFrame': 'Baseline, Moxibustion 5 min, Moxibustion 10 min, Moxibustion 15 min, 5 minutes after stopping moxibustion', 'description': 'Infrared thermal imaging was used to record baseline temperature and the temperature change of corresponding sites along the Heart and Lung meridians.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart and lung meridians', 'site specificity', 'infrared thermography', 'moxibustion', 'thermal transport'], 'conditions': ['Meridians']}, 'referencesModule': {'references': [{'pmid': '35647050', 'type': 'DERIVED', 'citation': 'Li X, Jiang Y, Hu H, Lou J, Zhang Y, He X, Wu Y, Fang J, Shao X, Fang J. The Moxibustion-Induced Thermal Transport Effect Between the Heart and Lung Meridians With Infrared Thermography. Front Cardiovasc Med. 2022 May 13;9:817901. doi: 10.3389/fcvm.2022.817901. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes. Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study was designed to assess the heat transport characteristics of meridian phenomenon for the Heart and Lung meridians by using infrared thermography. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.', 'detailedDescription': '80 eligible subjects were finally included. Among them, 40 participants were assigned to the lung meridian intervention group, and 40 participants were assigned to the heart meridian intervention group. All 80 participants completed the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had recent medical examination records confirming the absence of cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological diseases\n* 20 ≤ age ≤ 40 years, male or female\n* Had the ability to communicate with others normally\n* An understanding of the entire study protocol\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Had mental illnesses, severe depression, alcohol dependence or a history of drug abuse\n* Pregnant or lactating\n* Were participating in other trials'}, 'identificationModule': {'nctId': 'NCT05330403', 'briefTitle': 'The Moxibustion-Induced Thermal Transport Effect Between The Heart And Lung Meridians', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zhejiang Chinese Medical University'}, 'officialTitle': 'The Moxibustion-Induced Thermal Transport Effect Between The Heart And Lung Meridians With Infrared Thermography', 'orgStudyIdInfo': {'id': '2019ZY010-MERIDIAN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the lung meridian intervention group', 'description': 'moxibustion intervention was performed over Site 1 (LU5) of the lung meridian', 'interventionNames': ['Procedure: Moxibustion']}, {'type': 'EXPERIMENTAL', 'label': 'the heart meridian intervention group', 'description': 'moxibustion intervention was applied over Site 4 (HT3) of the heart meridian', 'interventionNames': ['Procedure: Moxibustion']}], 'interventions': [{'name': 'Moxibustion', 'type': 'PROCEDURE', 'description': 'In this study, suspended moxibustion was performed by holding an ignited moxa stick at a certain distance (about 3-4 cm) over the skin surface, keeping the moxibustion Site warm without burning the skin.\n\nIn the heart meridian intervention group, moxibustion was applied over Site 4 (HT3) of the heart meridian.\n\nIn the lung meridian intervention group, moxibustion was performed over Site 1 (LU5) of the lung meridian.', 'armGroupLabels': ['the heart meridian intervention group', 'the lung meridian intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hanzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'the Third affiliated hospital of Zhejiang Chinese Medical university'}], 'overallOfficials': [{'name': 'Jianqiao Fang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Chinese Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Chinese Medical University', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The Third Affiliated hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Jianqiao Fang', 'investigatorAffiliation': 'Zhejiang Chinese Medical University'}}}}