NCT07457333Enrolling by invitationPhase 1/2
Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Stroke
- NCT number
- NCT07457333
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 1 Feb 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another interventional clinical trial within 30 days prior to enrollment.
Other illness
- 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.
Lab values
- Complicated with severe cardiac, hepatic, renal, or hematopoietic system dysfunction (as defined by specific laboratory criteria).
Other
- Non-aneurysmal SAH (e.g., caused by trauma, arteriovenous malformation, etc.).
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 2ndAffiliated Hospital, School of Medicine, Zhejiang Universit Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.