Beta-sitosterol Added to Standard Care After Bleeding Around the Brain
Tests beta-sitosterol alongside usual treatment in adults with subarachnoid hemorrhage.
Plain-language title generated from the registry record
Registry title: Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07457333, who can take part
Where in China
- 2ndAffiliated Hospital, School of Medicine, Zhejiang UniversitHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07457333
- Record updated
- 11 March 2026
- Original description
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.Read full original descriptionShow less
Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy
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.
Inclusion: 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.
Exclusion: Participation in another interventional clinical trial within 30 days prior to enrollment; Secondary to other severe intracranial diseases (e.g., large intracerebral hematoma, severe brain herniation); Known allergy to Gastrodia elata or any of its components; Any other condition that, in the judgment of the investigator, makes the patient unsuitable for participation in this study; Complicated with severe cardiac, hepatic, renal, or hematopoietic system dysfunction (as defined by specific laboratory criteria); Non-aneurysmal SAH (e.g., caused by trauma, arteriovenous malformation, etc.); Pregnancy or breastfeeding.