Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 6:56 AM
Study NCT ID:
NCT05200234
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2022-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053771', 'term': 'nattokinase'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-16', 'studyFirstSubmitDate': '2022-01-17', 'studyFirstSubmitQcDate': '2022-01-17', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the scores of Montreal Cognitive Assessment', 'timeFrame': '6 months', 'description': 'Total score of 30'}], 'secondaryOutcomes': [{'measure': 'Changes in the scores of Mini-mental State Examination', 'timeFrame': '6 months', 'description': 'Total score of 30'}, {'measure': 'Changes in cerebral blood flow in the territory of the culprit artery', 'timeFrame': '6 months'}, {'measure': 'Changes in the scores of Colour Trail Test', 'timeFrame': '6 months'}, {'measure': 'Changes in the scores of Hopkins Verbal Learning Test', 'timeFrame': '6 months'}, {'measure': 'Changes in the scores of clock drawing test', 'timeFrame': '6 months'}, {'measure': 'Changes in the scores of Animal Fluency Test', 'timeFrame': '6 months'}, {'measure': 'Changes in the scores of Olfactory stick test', 'timeFrame': '6 months'}, {'measure': 'Incidence of stroke event including ischemic and hemorrhagic stroke', 'timeFrame': '6 months'}, {'measure': 'Changes in cerebral glymphatic function', 'timeFrame': '6 months', 'description': 'assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)'}, {'measure': 'Changes in metabonomics', 'timeFrame': '6 months', 'description': 'include blood and fecal samples'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intracranial / Carotid Stenosis', 'Cerebral Blood Flow', 'Cognitive Function'], 'conditions': ['Cerebral Blood Flow', 'Cognitive Function']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial will be conducted. Patients with asymptomatic intracranial / carotid stenosis will be randomized into two arms (1:1): an intervention arm and a control arm. Patients in the intervention arm will be treated with standard medical treatment combined with Natto Products V, whereas Patient in the control arm will be treated with only standard medical treatment . And the impact of Natto Products V on improving cerebral blood flow and cognitive function in patients with asymptomatic intracranial / carotid stenosis will be assessed by neuropsychological scale and multimode magnetic resonance imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥ 40 years\n* ≥ 50% stenosis in unilateral intracranial / carotid artery\n* Written informed consent available\n\nExclusion Criteria:\n\n* Previous history of major head trauma and any intracranial surgery\n* Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions\n* Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement\n* severe loss of vision, hearing, or communicative ability\n* plan to be treated with surgery'}, 'identificationModule': {'nctId': 'NCT05200234', 'acronym': 'ICC-PACS', 'briefTitle': 'Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS)', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS): a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ICC-PACS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Nattokinase + standard medical treatment', 'interventionNames': ['Drug: Nattokinase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo + Standard medical treatment', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nattokinase', 'type': 'DRUG', 'description': 'Nattokinase + standard treatment', 'armGroupLabels': ['Intervention group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo+ standard treatment', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Lou, PhD, MD', 'role': 'CONTACT', 'email': 'lm99@zju.edu.cn', 'phone': '13958007213'}], 'facility': 'Second Affilated Hospital of Zhejiang University, School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Min Lou, PhD, MD', 'role': 'CONTACT', 'email': 'loumingxc@vip.sina.com', 'phone': '13958007213'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}