Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supplementation of β -sitosterol, Standard medical treatment.
- Who it may be relevant to
- Registry conditions: Subarachnoid Haemorrhagic Stroke. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- the modified Rankin Scale (mRS) score [Time frame: From baseline through the 6-month follow-up period (with intensive monitoring during the first 14 days).]
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: At 90 days (±7 days) post-treatment initiation.]
Secondary outcome measures (5)
- Glasgow Outcome Scale Extended (GOS-E) score [Time frame: At 1 month, 3 months (±7 days), and 6 months (±14 days).]
- Montreal Cognitive Assessment (MoCA) score [Time frame: At baseline (enrollment), 1 month, 3 months, and 6 months.]
- Short Form Health Survey (SF-36) score [Time frame: At 90 days (±7 days) and 180 days (±14 days).]
- Radiological Outcomes Assessed by MRI (Cerebral Infarction, Edema) [Time frame: At baseline, 1 month, 3 months, and 6 months.]
- Serum Levels of Inflammatory Cytokines [Time frame: At baseline, 1 month, 3 months, and 6 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- 2ndAffiliated Hospital, School of Medicine, Zhejiang Universit — Hangzhou
Identifiers
NCT: NCT07457333 · 2026-0151