Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy (NCT07457333) | Clinical Trial Compass
By InvitationPhase 1/2
Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy
China40 participantsStarted 2026-02-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the modified Rankin Scale (mRS) score
Timeframe: From baseline through the 6-month follow-up period (with intensive monitoring during the first 14 days).
2
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: At 90 days (±7 days) post-treatment initiation.
Trial details
NCT IDNCT07457333
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University