Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-05-02 @ 6:04 PM
Study NCT ID:
NCT02993367
Status:
UNKNOWN
Last Update Posted:
2017-03-16
First Post:
2016-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-15', 'studyFirstSubmitDate': '2016-12-08', 'studyFirstSubmitQcDate': '2016-12-12', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of Cognitive function', 'timeFrame': 'Time points 0, 1, 3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'change of brain function', 'timeFrame': 'Time point at 0, 1, 3, 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Butylphthalide Soft Capsules', 'VCIND', 'fMRI'], 'conditions': ['Vascular Cognitive Impairment no Dementia']}, 'referencesModule': {'references': [{'pmid': '26086183', 'type': 'RESULT', 'citation': 'Jia J, Wei C, Liang J, Zhou A, Zuo X, Song H, Wu L, Chen X, Chen S, Zhang J, Wu J, Wang K, Chu L, Peng D, Lv P, Guo H, Niu X, Chen Y, Dong W, Han X, Fang B, Peng M, Li D, Jia Q, Huang L. The effects of DL-3-n-butylphthalide in patients with vascular cognitive impairment without dementia caused by subcortical ischemic small vessel disease: A multicentre, randomized, double-blind, placebo-controlled trial. Alzheimers Dement. 2016 Feb;12(2):89-99. doi: 10.1016/j.jalz.2015.04.010. Epub 2015 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to progress to dementia, but there have been no proper large-scale intervention trials dedicated to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical VCIND) represents a relatively homogeneous disease process and is a suitable target for therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft Capsules is effective for cognitive impairment of vascular origin. In this randomized, double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of Butylphthalide Soft Capsules in patients with VCIND.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Literate Han Chinese aged from 40 to 65 years\n* MMSE ≥24\n* Normal or slightly impaired activities of daily living\n* The MRI entry criteria are as follows:\n\n * Subcortical small infarcts (3-20 mm in diameter),or one or more strategically located subcortical small infarcts in the caudate nucleus globus pallidus, or thalamus\n * Absence of cortical and watershed infarcts, hemorrhages, hydrocephalus, and WMLs with specific causes (e.g., multiple sclerosis); and\n * No hippocampal or entorhinal cortex atrophy (scored 0 according to medial temporal lobe atrophy scale of Scheltens)\n\nExclusion Criteria:\n\n* Patients with Diabetes mellitus\n* Disorders other than subcortical VCIND that may affect cognition; the score of Hamilton depression scale more than 17 or schizophrenia\n* Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease; cancer; alcoholism; drug addiction; use of medications that may affect cognitive functioning\n* Known hypersensitivity to celery\n* Inability to undergo a brain MRI'}, 'identificationModule': {'nctId': 'NCT02993367', 'acronym': 'EBSCPVCIND', 'briefTitle': 'The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Hebei Medical University'}, 'officialTitle': 'The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND:A Randomized, Double-blind,and Neuroimaging Study', 'orgStudyIdInfo': {'id': 'ZYF55688'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the Butylphthalide Soft Capsules group', 'description': '600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months', 'interventionNames': ['Drug: Butylphthalide Soft Capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'the placebo group', 'description': '60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months', 'interventionNames': ['Drug: Placebo Butylphthalide Soft Capsules']}], 'interventions': [{'name': 'Butylphthalide Soft Capsules', 'type': 'DRUG', 'description': 'DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.Butylphthalide Soft Capsules is the oral preparation.', 'armGroupLabels': ['the Butylphthalide Soft Capsules group']}, {'name': 'Placebo Butylphthalide Soft Capsules', 'type': 'DRUG', 'armGroupLabels': ['the placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhu yifei, master', 'role': 'CONTACT', 'email': '13831155688@163.com', 'phone': '+8613303046666'}, {'name': 'liang panpan, master', 'role': 'CONTACT', 'email': '674691785@qq.com', 'phone': '+8617717711528'}], 'facility': 'Second Affiliated Hospital of Hebei medical university', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'centralContacts': [{'name': 'Yifei Zhu, M.D.', 'role': 'CONTACT', 'email': '13831155688@163.com', 'phone': '+8613303046666'}, {'name': 'Panpan Liang, M.D.', 'role': 'CONTACT', 'email': '2354672781@qq.com', 'phone': '+8617717711528'}], 'overallOfficials': [{'name': 'Yifei Zhu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Hebei Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yifei Zhu', 'investigatorAffiliation': 'The Second Hospital of Hebei Medical University'}}}}