Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the modified Rankin Scale (mRS) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years, regardless of gender.
- •Confirmed diagnosis of spontaneous aneurysmal subarachnoid hemorrhage (aSAH) by head CT or cerebral angiography (DSA/CTA).
- •Time from symptom onset to planned first dose administration within 48 hours.
- •Aneurysm successfully secured by surgical clipping or endovascular intervention.
- •World Federation of Neurosurgical Societies (WFNS) grade I-III.
- •Written informed consent signed by the patient or their legal representative.
排除标准
- •Non-aneurysmal SAH (e.g., caused by trauma, arteriovenous malformation, etc.).
- •Secondary to other severe intracranial diseases (e.g., large intracerebral hematoma, severe brain herniation).
- •Complicated with severe cardiac, hepatic, renal, or hematopoietic system dysfunction (as defined by specific laboratory criteria).
- •Known allergy to Gastrodia elata or any of its components.
- •Pregnancy or breastfeeding.
- •Participation in another interventional clinical trial within 30 days prior to enrollment.
- •Any other condition that, in the judgment of the investigator, makes the patient unsuitable for participation in this study.
研究组 & 干预措施
Control Group
Standard treatment
干预措施: Standard medical treatment (Other)
Experimental Group
Standard treatment + sitosterol treatment
干预措施: Supplementation of β -sitosterol (Drug)
Experimental Group
Standard treatment + sitosterol treatment
干预措施: Standard medical treatment (Other)
结局指标
主要结局
the modified Rankin Scale (mRS) score
时间窗: From baseline through the 6-month follow-up period (with intensive monitoring during the first 14 days).
Functional independence measured by the modified Rankin Scale (mRS) score. A favorable outcome is typically defined as mRS score 0-2.
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: At 90 days (±7 days) post-treatment initiation.
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).
次要结局
- Serum Levels of Inflammatory Cytokines(At baseline, 1 month, 3 months, and 6 months.)
- Glasgow Outcome Scale Extended (GOS-E) score(At 1 month, 3 months (±7 days), and 6 months (±14 days).)
- Montreal Cognitive Assessment (MoCA) score(At baseline (enrollment), 1 month, 3 months, and 6 months.)
- Short Form Health Survey (SF-36) score(At 90 days (±7 days) and 180 days (±14 days).)
- Radiological Outcomes Assessed by MRI (Cerebral Infarction, Edema)(At baseline, 1 month, 3 months, and 6 months.)