Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 5:50 PM
Study NCT ID:
NCT00608660
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
2008-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Acupuncture to Treat Bell's Palsy According to Different Stages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020330', 'term': 'Bell Palsy'}, {'id': 'D005158', 'term': 'Facial Paralysis'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'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': 'D009071', 'term': 'Moxibustion'}, {'id': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-15', 'studyFirstSubmitDate': '2008-01-04', 'studyFirstSubmitQcDate': '2008-01-24', 'lastUpdatePostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'House-Brackmann scale （Global Score）', 'timeFrame': 'a week'}], 'secondaryOutcomes': [{'measure': 'Classification Score Of Facial Paralysis Degree', 'timeFrame': 'a week'}, {'measure': 'Facial Disability Index', 'timeFrame': 'a week'}, {'measure': 'WHOQOL-BREF scale', 'timeFrame': 'two week'}, {'measure': 'House-Brackmann scale （Regional Score）', 'timeFrame': 'a week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peripheral Facial Paralysis', 'Acupuncture', 'RCT'], 'conditions': ["Bell's Palsy"]}, 'referencesModule': {'references': [{'pmid': '21435214', 'type': 'DERIVED', 'citation': 'Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy", 'detailedDescription': "The result of this trial (available in 2009) aims to testify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy, and to approach a best acupuncture treatment among these five different methods for treating Bell's Palsy"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients who meet the diagnosis, stages, location criteria\n* the first time to onset the disease\n* between 1 and 70 days with the onset time of facial palsy\n* on one side of the face paralysis\n* between 15 and 70 years old with the onset age of facial palsy\n* willing to finish the whole observation period\n* with written consent form signed by themselves.\n\nExclusion Criteria:\n\n* facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma\n* facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis\n* patient with Hunt's syndrome\n* patient with facial spasm\n* pregnant women or women in lactation\n* patients are participating other clinical research"}, 'identificationModule': {'nctId': 'NCT00608660', 'briefTitle': "Randomized Controlled Trial of Acupuncture to Treat Bell's Palsy According to Different Stages", 'organization': {'class': 'OTHER', 'fullName': 'Chengdu University of Traditional Chinese Medicine'}, 'officialTitle': "Studying of Acupuncture for Bell's Palsy According to Different Stages", 'orgStudyIdInfo': {'id': '2006BAI12B03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': "staging acupuncture for treating Bell's Palsy", 'interventionNames': ['Other: acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': "staging acupuncture and moxibustion for treating Bell's Palsy", 'interventionNames': ['Other: acupuncture and moxibustion']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': "staging electroacupuncture for treating Bell's Palsy", 'interventionNames': ['Other: electroacupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': "staging acupuncture along Yangming musculature for treating Bell's Palsy", 'interventionNames': ['Other: acupuncture along yangming tendons']}, {'type': 'EXPERIMENTAL', 'label': 'E', 'description': "non-staging acupuncture for treating Bell's Palsy", 'interventionNames': ['Other: acupuncture']}], 'interventions': [{'name': 'acupuncture', 'type': 'OTHER', 'description': 'staging acupuncture', 'armGroupLabels': ['A']}, {'name': 'acupuncture and moxibustion', 'type': 'OTHER', 'description': 'staging acupuncture and moxibustion', 'armGroupLabels': ['B']}, {'name': 'electroacupuncture', 'type': 'OTHER', 'description': 'staging electroacupuncture', 'armGroupLabels': ['C']}, {'name': 'acupuncture along yangming tendons', 'type': 'OTHER', 'description': 'staging acupuncture along Yangming musculature', 'armGroupLabels': ['D']}, {'name': 'acupuncture', 'type': 'OTHER', 'description': 'non-staging acupuncture', 'armGroupLabels': ['E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610075', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chengdu university of TCM', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Ying Li, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acupuncture&Moxibustion college of chengdu TCM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'LiYing', 'oldOrganization': 'Acupuncture & Tuina college of chengdu univeristy of TCM'}}}}