Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT01697761
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
2012-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2012-09-28', 'studyFirstSubmitQcDate': '2012-09-28', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CDAI', 'timeFrame': '2 years', 'description': "Crohn's Disease Activity Index"}], 'secondaryOutcomes': [{'measure': 'Inflammatory factors', 'timeFrame': '2 years', 'description': 'Intestinal mucosa of Th17/Treg,IL-6,IL-17,IL-23,etc'}, {'measure': 'Neurotransmitter', 'timeFrame': '2 years', 'description': 'Intestinal mucosa of 5-HT,DA,SP,VIP and their receptors etc'}, {'measure': 'IBDQ', 'timeFrame': '2 years', 'description': 'Inflammatory Bowel Disease Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Crohn's disease,acupuncture,moxibustion,inflammation factors"], 'conditions': ["Crohn's Disease", 'CAM']}, 'referencesModule': {'references': [{'pmid': '25152604', 'type': 'DERIVED', 'citation': "Bao CH, Zhao JM, Liu HR, Lu Y, Zhu YF, Shi Y, Weng ZJ, Feng H, Guan X, Li J, Chen WF, Wu LY, Jin XM, Dou CZ, Wu HG. Randomized controlled trial: moxibustion and acupuncture for the treatment of Crohn's disease. World J Gastroenterol. 2014 Aug 21;20(31):11000-11. doi: 10.3748/wjg.v20.i31.11000."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy.", 'detailedDescription': "The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy.\n\nThrough treating active Crohn's disease by acupuncture and moxibustion therapies for 12 weeks, we are aim to observe the efficiency and the probably change of Inflammatory factors and Neurotransmitter of colonic mucosa and we may elucidate the mechanism of the efficiency of acupuncture and moxibustion therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-70 years;\n* Crohn\'s Disease Activity Index \\[CDAI\\]\\>150 and \\<450;\n* not taking any medication or taking salicylates, prednisone ( dose≤ 15mg and at least have taken a month ), after entering the study the dose remained constant;\n* Not taking immunosuppressive agents or use " with " biological preparations within 3 months prior to entering the study\n* signing a written informed consent form.\n\nExclusion Criteria:\n\n* Severe Crohn\'s disease patients or patients in remission ( CDAI \\> 450 or \\< 150 );\n* The pregnancy or lactation period patients ;\n* patients associated with heart, brain, liver, kidney and hematopoietic system disease;\n* The psychiatric patients;\n* Patients with other serious diseases.'}, 'identificationModule': {'nctId': 'NCT01697761', 'briefTitle': "Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Institute of Acupuncture, Moxibustion and Meridian'}, 'officialTitle': "Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease and Its Regulation Mechanism to the Immune Homeostasis Mediated by Th17/Treg Cells", 'orgStudyIdInfo': {'id': 'SHACU-201202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'treat by moxibustion and acupuncture', 'interventionNames': ['Other: Treatment Group']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'treat by Sham acupuncture and moxibustion', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Treatment Group', 'type': 'OTHER', 'otherNames': ['acupuncture and moxibustion group', 'acupuncture and Herbs-partitioned moxibustion group'], 'description': 'patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes，3 times a week for 12 weeks', 'armGroupLabels': ['Treatment Group']}, {'name': 'Control Group', 'type': 'OTHER', 'otherNames': ['Sham acupuncture and moxibustion group'], 'description': 'patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Institute of Acupuncture-Moxibustion and Merdian', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Wu Huangan, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Institute of Acupuncture, Moxibustion and Meridian'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Institute of Acupuncture, Moxibustion and Meridian', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}