NCT07457333

Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy

• Status: Enrolling By Invitation
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subarachnoid Haemorrhagic Stroke

Interventions

Type	Name	Description
DRUG	Supplementation of β -sitosterol	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.
OTHER	Standard medical treatment	Standard medical treatment

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-03-09
• Last updated: 2026-03-11

Locations

1 site across 1 country: China