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

NCT07457333 | Enrolling By Invitation Phase 1

• 1 other identifier: 2026-0151
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• the modified Rankin Scale (mRS) score

  Functional independence measured by the modified Rankin Scale (mRS) score. A favorable outcome is typically defined as mRS score 0-2.

  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)

  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).

  At 90 days (±7 days) post-treatment initiation.

Secondary Outcomes (5)

• Glasgow Outcome Scale Extended (GOS-E) score

  At 1 month, 3 months (±7 days), and 6 months (±14 days).

• Montreal Cognitive Assessment (MoCA) score

  At baseline (enrollment), 1 month, 3 months, and 6 months.

• Short Form Health Survey (SF-36) score

  At 90 days (±7 days) and 180 days (±14 days).

• Radiological Outcomes Assessed by MRI (Cerebral Infarction, Edema)

  At baseline, 1 month, 3 months, and 6 months.

• Serum Levels of Inflammatory Cytokines

  At baseline, 1 month, 3 months, and 6 months.

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Standard treatment

Other: Standard medical treatment

Experimental Group

EXPERIMENTAL

Standard treatment + sitosterol treatment

Drug: Supplementation of β -sitosterol; Other: Standard medical treatment

Interventions

Supplementation of β -sitosterol DRUG

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.

Experimental Group

Standard medical treatment OTHER

Standard medical treatment

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang Universit

Hangzhou, Zhejiang, 310000, China

Location

Study Officials

• Yan Chen

  2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)