Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-05 @ 9:21 PM
Study NCT ID:
NCT01806233
Status:
UNKNOWN
Last Update Posted:
2021-08-11
First Post:
2013-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lu's Acupuncture and Moxibustion Treatment on Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D010243', 'term': 'Paralysis'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-10', 'studyFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simplified Fugl-Meyer Scale', 'timeFrame': '8 weeks', 'description': '5 times a week, last 4 weeks,assessment on 4 weeks and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Burden of Stroke Scale-Boss', 'timeFrame': '6 months', 'description': '5 times a week, last 4 weeks,assessment on 8 weeks and 6 months'}, {'measure': 'Modified Barthel Index', 'timeFrame': '6 months', 'description': '5 times a week, last 4 weeks,assessment on 8 weeks and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ischemic Stroke', 'Paralysis']}, 'referencesModule': {'references': [{'pmid': '32733577', 'type': 'DERIVED', 'citation': 'Xu J, Pei J, Fu QH, Zhan YJ. The Prognostic Value of Traditional Chinese Medicine Symptoms in Acute Ischemic Stroke: A Pilot Study. Evid Based Complement Alternat Med. 2020 Jul 15;2020:1520851. doi: 10.1155/2020/1520851. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'There will be successive changes in traditional Chinese medicine rehabilitation for stroke patients with limb hemiparetic through therapy of acupuncture and moxibustion.', 'detailedDescription': "There will be difference in stroke outcomes of ischemic stroke patients with limb hemiparetic from acute to chronic phase under Lu' acupuncture and moxibustion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The ages of stroke patients from 40 years old to 70 years old.\n* The principle diagnosis according to \\<diagnosis-treatment criteria of stroke(trial implementation)\\>formulated by Collaboration Acute Brain Diseases of State Administration of Traditional Chinese Medicine in 1996；Ischemic stroke confirmed by CT brain or MRI brain,with stable medical condition and awareness clear.\n* Recent stroke from 7 days to 6 months after onset.\n* Stroke with limb movement disorder and hypomyotonia，NIHSS≤10，ASHWORTH≤1，GCS\\>8.\n* Written informed consent by inpatient.\n\nExclusion Criteria:\n\n* Stroke with conscious disturbance or serious cognitive impairment.\n* Stroke with limb spasm；ASHWORTH≥1.\n* Having cardiac pacemaker，metallic foreign body in treatment position，or hemorrhagic tendency.\n* Being oversensitive to electrical stimulus.'}, 'identificationModule': {'nctId': 'NCT01806233', 'acronym': 'LAMTS', 'briefTitle': "Lu's Acupuncture and Moxibustion Treatment on Stroke", 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Traditional Chinese Medicine'}, 'officialTitle': "Lu' Acupuncture and Moxibustion Treatment on Ischemic Stroke", 'orgStudyIdInfo': {'id': '3534123123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'acupuncture', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'Rehabilitation', 'description': 'rehabilitation exercise', 'interventionNames': ['Procedure: Rehabilitation']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': 'The treatment group：60 patients receive Acupuncture ，selecting acupoint on:Shenting（DU24), Baihui（DU20）, Fengchi（GB20), Hanyan（GB4）, Jianyu（LI15）, Quchi（LI11）,Waiguan（SJ5）, Zusanli（ST36）, Fenglong（ST40）, Xingjian(LV2), Yongquan（KI1）, 20minutes each time，ten times / treatment course，two treatment courses in total.', 'armGroupLabels': ['Acupuncture']}, {'name': 'Rehabilitation', 'type': 'PROCEDURE', 'otherNames': ['Rehabilitation treatment'], 'description': 'The matched group：60 patients receive rehabilitation treatment，45 minutes each once，ten time as a period of treatment，two periods of treatment in all.', 'armGroupLabels': ['Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qinhui Fu, MD', 'role': 'CONTACT', 'email': 'ff777315@163.com', 'phone': '+86-21-64385700', 'phoneExt': '3534'}, {'name': 'Jun Wang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Longhua Hospital,Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jian Pei, MD', 'role': 'CONTACT', 'email': 'jianpei99@yahoo.com', 'phone': '021-64385700', 'phoneExt': '3534'}], 'overallOfficials': [{'name': 'Jian Pei, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai University of Traditional Chinese Medicine'}, {'name': 'Yi Wu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Huashan Hospital'}, {'name': 'Jie Jia, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Huashan Hospital'}, {'name': 'Yi Song, MM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai University of Traditional Chinese Medicine'}, {'name': 'Zouqin Huang, MM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai University of Traditional Chinese Medicine'}, {'name': 'Xiaoxin You, MM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai University of Traditional Chinese Medicine'}, {'name': 'Qinhui FU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai University of Traditional Chinese Medicine'}, {'name': 'Jun Wang, MM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai University of Traditional Chinese Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}