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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.
This 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Standard treatment |
|
| Experimental Group | Experimental | Standard treatment + sitosterol treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplementation of β -sitosterol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the modified Rankin Scale (mRS) score | Functional independence measured by the modified Rankin Scale (mRS) score. A favorable outcome is typically defined as mRS score 0-2. | From baseline through the 6-month follow-up period (with intensive monitoring during the first 14 days). |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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). | At 90 days (±7 days) post-treatment initiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Outcome Scale Extended (GOS-E) score | 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. | At 1 month, 3 months (±7 days), and 6 months (±14 days). |
| Montreal Cognitive Assessment (MoCA) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Chen | 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2ndAffiliated Hospital, School of Medicine, Zhejiang Universit | Hangzhou | Zhejiang | 310000 | China |
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|
| Standard medical treatment | Other | Standard medical treatment |
|
Montreal Cognitive Assessment (MoCA) score to evaluate cognitive impairment, with scores ranging from 0 to 30 and higher scores indicating better cognitive function. |
| At baseline (enrollment), 1 month, 3 months, and 6 months. |
| Short Form Health Survey (SF-36) score | 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. | At 90 days (±7 days) and 180 days (±14 days). |
| Radiological Outcomes Assessed by MRI (Cerebral Infarction, Edema) | 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. | At baseline, 1 month, 3 months, and 6 months. |
| Serum Levels of Inflammatory Cytokines | Dynamic changes in serum levels of inflammatory cytokines (e.g., TNF-α, IL-1β) and neuroprotective factors. | At baseline, 1 month, 3 months, and 6 months. |