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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Standard medical treatment: Standard medical treatment

Study 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.

Eligibility

Primary outcome measure(s)

• the modified Rankin Scale (mRS) score — 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) — 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).

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China