Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-26 @ 1:33 PM
Study NCT ID:
NCT01274793
Status:
UNKNOWN
Last Update Posted:
2015-03-19
First Post:
2011-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C062720', 'term': 'mosapride'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-01-11', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acupuncture benefits functional constipation', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['functional constipation', 'functional diarrhea', 'acupuncture'], 'conditions': ['Functional Constipation', 'Functional Diarrhea']}, 'referencesModule': {'references': [{'pmid': '35027932', 'type': 'DERIVED', 'citation': 'Xu X, Zhang M, Wu X, Zheng C, Huang G. The Effect of Electroacupuncture Treatment with Different Intensities for Functional Diarrhea: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2022 Jan 4;2022:2564979. doi: 10.1155/2022/2564979. eCollection 2022.'}, {'pmid': '24143917', 'type': 'DERIVED', 'citation': 'Zheng CH, Huang GY, Xu XH, Wang Y, Zhang MM, Wang W, Jing XH, Zhu B. Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial. Trials. 2013 Oct 22;14:344. doi: 10.1186/1745-6215-14-344.'}]}, 'descriptionModule': {'briefSummary': 'the objective of this study is to investigate the Dose-Effect Relationship of Acupuncture with Two-ways Regulation Effect to Treat Functional Enteropathy', 'detailedDescription': 'eligibility criteria: functional constipation,functional diarrheaļ¼irritable bowel syndrome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* function constipation function diarrhea\n\nExclusion Criteria:\n\n* not function constipation not function diarrhea'}, 'identificationModule': {'nctId': 'NCT01274793', 'briefTitle': 'Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Multicentre Randomized Controlled Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy', 'orgStudyIdInfo': {'id': '2011CB505203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mosapride', 'description': 'In the control group were orally administered 5 mg mosapride citrate tablet s three times a day for 4 continu ous weeks if no severe adverse effects were found.', 'interventionNames': ['Drug: Mosapride Citrate tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Low-dose acupuncture', 'description': 'In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants', 'interventionNames': ['Device: Low-dose acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose acupuncture', 'description': "In this group,the current was strong enough to reach the patients'tolerance threshold value.", 'interventionNames': ['Device: High-dose acupuncture']}], 'interventions': [{'name': 'Mosapride Citrate tablet', 'type': 'DRUG', 'otherNames': ['GASMOTIN'], 'description': 'Orally administered 5 mg mosapride citrate tablet s three times a day for 4 continuous weeks if no severe adverse effects were found.', 'armGroupLabels': ['Mosapride']}, {'name': 'Low-dose acupuncture', 'type': 'DEVICE', 'description': 'In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants', 'armGroupLabels': ['Low-dose acupuncture']}, {'name': 'High-dose acupuncture', 'type': 'DEVICE', 'description': "In this group,the current was strong enough to reach the patients'tolerance threshold value.", 'armGroupLabels': ['High-dose acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangying Huang, doctor', 'role': 'CONTACT', 'email': 'Gyhuang@tjh.tjmu.edu.cn', 'phone': '86-027-8366-3266'}, {'name': 'Mingmin Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Cuihong Zheng, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fan Xiong, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ying Wang, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Man Tian, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Guangying Huang, doctor', 'role': 'CONTACT', 'email': 'gyhuang@tjh.tjmu.edu.cn', 'phone': '86-27-83663266'}], 'overallOfficials': [{'name': 'Guangying Huang, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'institute of integrated traditional chinese and western medicineļ¼Tongji meidical college,HUST'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Fifth Hospital of Wuhan', 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Guangzhou University of Traditional Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital', 'investigatorFullName': 'Guangying Huang', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}