Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-01 @ 9:53 AM
Study NCT ID:
NCT07457333
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-11
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the modified Rankin Scale (mRS) score', 'timeFrame': 'From baseline through the 6-month follow-up period (with intensive monitoring during the first 14 days).', 'description': 'Functional independence measured by the modified Rankin Scale (mRS) score. A favorable outcome is typically defined as mRS score 0-2.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'At 90 days (±7 days) post-treatment initiation.', 'description': 'Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), with specific focus on allergic reactions, liver function (ALT/AST), renal function (Cr/BUN), and coagulation parameters (PT/APTT).'}], 'secondaryOutcomes': [{'measure': 'Glasgow Outcome Scale Extended (GOS-E) score', 'timeFrame': 'At 1 month, 3 months (±7 days), and 6 months (±14 days).', 'description': 'Glasgow Outcome Scale Extended (GOS-E) score to assess global disability and recovery, with scores ranging from 1 to 8 and higher scores indicating better outcomes.'}, {'measure': 'Montreal Cognitive Assessment (MoCA) score', 'timeFrame': 'At baseline (enrollment), 1 month, 3 months, and 6 months.', 'description': 'Montreal Cognitive Assessment (MoCA) score to evaluate cognitive impairment, with scores ranging from 0 to 30 and higher scores indicating better cognitive function.'}, {'measure': 'Short Form Health Survey (SF-36) score', 'timeFrame': 'At 90 days (±7 days) and 180 days (±14 days).', 'description': 'Short Form Health Survey (SF-36) score to assess health-related quality of life, with scores for each domain ranging from 0 to 100 and higher scores indicating better health status.'}, {'measure': 'Radiological Outcomes Assessed by MRI (Cerebral Infarction, Edema)', 'timeFrame': 'At baseline, 1 month, 3 months, and 6 months.', 'description': 'Incidence of Delayed Cerebral Ischemia (DCI) and other neurological worsening events during the acute phase, diagnosed by imaging findings. Radiological assessments will be performed using computed tomography (CT) or magnetic resonance imaging (MRI) to evaluate: 1) Resolution of subarachnoid hemorrhage, measured by the Subarachnoid Hemorrhage Resolution Scale; 2) Incidence of cerebral infarction; 3) Incidence and severity of cerebral edema; and 4) Changes in meningeal lymphatic drainage function, measured by Dynamic Contrast-Enhanced MRI parameters.'}, {'measure': 'Serum Levels of Inflammatory Cytokines', 'timeFrame': 'At baseline, 1 month, 3 months, and 6 months.', 'description': 'Dynamic changes in serum levels of inflammatory cytokines (e.g., TNF-α, IL-1β) and neuroprotective factors.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subarachnoid Haemorrhagic Stroke']}, 'descriptionModule': {'briefSummary': 'Subarachnoid Hemorrhage (SAH), a devastating form of stroke, is associated with high mortality and disability rates due to complex secondary brain injuries-including neuroinflammation, oxidative stress, and blood-brain barrier disruption-for which effective neuroprotective treatments remain scarce. Inspired by the neuroprotective properties of the traditional Chinese herb Gastrodia elata, this study identifies a novel bioactive mechanism: its extracellular vesicles (G-EVs) are naturally enriched with β-Sitosterol, a plant sterol with proven anti-inflammatory, antioxidant, and endothelial-protective effects.\n\nThis project represents the first clinical investigation into the therapeutic potential of β-Sitosterol for patients with aneurysmal SAH. Given the excellent safety profile of β-Sitosterol as a widely used dietary supplement, this study aims to evaluate its safety and tolerability in SAH patients while preliminarily exploring its efficacy in improving neurological outcomes. By analyzing key biomarkers of inflammation and oxidative stress, this research seeks to bridge the gap between traditional medicine and modern nanomedicine, offering a novel, safe, and accessible adjunct therapy for SAH and paving the way for plant-derived compounds in acute neurocritical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 75 years, regardless of gender.\n* Confirmed diagnosis of spontaneous aneurysmal subarachnoid hemorrhage (aSAH) by head CT or cerebral angiography (DSA/CTA).\n* Time from symptom onset to planned first dose administration within 48 hours.\n* Aneurysm successfully secured by surgical clipping or endovascular intervention.\n* World Federation of Neurosurgical Societies (WFNS) grade I-III.\n* Written informed consent signed by the patient or their legal representative.\n\nExclusion Criteria:\n\n* Non-aneurysmal SAH (e.g., caused by trauma, arteriovenous malformation, etc.).\n* Secondary to other severe intracranial diseases (e.g., large intracerebral hematoma, severe brain herniation).\n* Complicated with severe cardiac, hepatic, renal, or hematopoietic system dysfunction (as defined by specific laboratory criteria).\n* Known allergy to Gastrodia elata or any of its components.\n* Pregnancy or breastfeeding.\n* Participation in another interventional clinical trial within 30 days prior to enrollment.\n* Any other condition that, in the judgment of the investigator, makes the patient unsuitable for participation in this study.'}, 'identificationModule': {'nctId': 'NCT07457333', 'acronym': 'B-SMART', 'briefTitle': 'Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy', 'orgStudyIdInfo': {'id': '2026-0151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Standard treatment', 'interventionNames': ['Other: Standard medical treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Standard treatment + sitosterol treatment', 'interventionNames': ['Drug: Supplementation of β -sitosterol', 'Other: Standard medical treatment']}], 'interventions': [{'name': 'Supplementation of β -sitosterol', 'type': 'DRUG', 'description': 'Participants in the experimental arm will receive Nutricost β-Sitosterol Softgels. The total daily dose is 500 mg of β-Sitosterol, administered orally in two divided doses (e.g., 250 mg twice daily). The treatment will continue for a duration of 6 months.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Standard medical treatment', 'type': 'OTHER', 'description': 'Standard medical treatment', 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': '2ndAffiliated Hospital, School of Medicine, Zhejiang Universit', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Yan Chen', 'role': 'STUDY_DIRECTOR', 'affiliation': '2ndAffiliated Hospital, School of Medicine, Zhejiang University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}