Subarachnoid Haemorrhagic StrokePhase 1/2B-SMARTNCT07457333
Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy
A Phase 1/2 study testing Supplementation of β -sitosterol and Standard medical treatment in people with Subarachnoid Haemorrhagic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subarachnoid Haemorrhagic Stroke
- What is being tested?
- Supplementation of β -sitosterol and Standard medical treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
2ndAffiliated Hospital, School of Medicine, Zhejiang Universit
Hangzhou, Zhejiang, 310000
About this study
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
- Being tested
- Supplementation of β -sitosterol, Standard medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation of β -sitosterolDrug
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 treatmentOther
Standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Standard treatment Receives: Other: Standard medical treatment |
| Experimental Group | Experimental | Standard treatment + sitosterol treatment Receives: Drug: Supplementation of β -sitosterol; Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: At 90 days (±7 days) post-treatment initiation.
Secondary outcomes (5)
Glasgow Outcome Scale Extended (GOS-E) score
Glasgow Outcome Scale Extended (GOS-E) score to assess global disability and recovery, with scores ranging from 1 to 8 and higher scores indicating better outcomes.
Measured: At 1 month, 3 months (±7 days), and 6 months (±14 days).
Montreal Cognitive Assessment (MoCA) score
Montreal Cognitive Assessment (MoCA) score to evaluate cognitive impairment, with scores ranging from 0 to 30 and higher scores indicating better cognitive function.
Measured: At baseline (enrollment), 1 month, 3 months, and 6 months.
Short Form Health Survey (SF-36) score
Short Form Health Survey (SF-36) score to assess health-related quality of life, with scores for each domain ranging from 0 to 100 and higher scores indicating better health status.
Measured: At 90 days (±7 days) and 180 days (±14 days).
Radiological Outcomes Assessed by MRI (Cerebral Infarction, Edema)
Incidence of Delayed Cerebral Ischemia (DCI) and other neurological worsening events during the acute phase, diagnosed by imaging findings. Radiological assessments will be performed using computed tomography (CT) or magnetic resonance imaging (MRI) to evaluate: 1) Resolution of subarachnoid hemorrhage, measured by the Subarachnoid Hemorrhage Resolution Scale; 2) Incidence of cerebral infarction; 3) Incidence and severity of cerebral edema; and 4) Changes in meningeal lymphatic drainage function, measured by Dynamic Contrast-Enhanced MRI parameters.
Measured: At baseline, 1 month, 3 months, and 6 months.
Serum Levels of Inflammatory Cytokines
Dynamic changes in serum levels of inflammatory cytokines (e.g., TNF-α, IL-1β) and neuroprotective factors.
Measured: At baseline, 1 month, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Haemorrhagic StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Chen, Study director, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457333
- Sponsor's protocol ID
- 2026-0151
- Acronym
- B-SMART
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy
- ClinicalTrials.gov ID
- NCT07457333
- Acronym / sponsor ID
- B-SMART / 2026-0151
- Conditions
- Subarachnoid Haemorrhagic Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Standard medical treatmentStandard treatment |
| Experimental Group | Experimental | Drug: Supplementation of β -sitosterol, Other: Standard medical treatmentStandard treatment + sitosterol treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplementation of β -sitosterolParticipants 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. | Drug | Experimental Group |
| Standard medical treatmentStandard medical treatment | Other | Control Group, Experimental Group |
Primary outcome
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).
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)
Time frame: 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).
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Chen study director
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Supplementation of β -sitosterol and Standard medical treatment in people with Subarachnoid Haemorrhagic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.