Clinical Trials

Multiple clinical trials are evaluating the therapeutic potential of beta-sitosterol across metabolic and cerebrovascular indications. An early-phase Phase 1/Phase 2 trial sponsored by the Second Affiliated Hospital, Zhejiang University, School of Medicine is currently enrolling by invitation to investigate subarachnoid haemorrhagic stroke. Additionally, a completed study sponsored by the University of Lahore evaluated a beta-sitosterol-enriched dietary intervention targeting hyperlipidemia in obese individuals, demonstrating academic interest in managing lipid dysregulation and supporting vascular recovery.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07457333 ENROLLING_BY_INVITATION
Subarachnoid Haemorrhagic Stroke
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2026-02-01 PHASE1; PHASE2
NCT07696559 COMPLETED
Hyperlipidemia; Obese Individuals
University of Lahore
 2026-01-15

(data from https://clinicaltrials.gov, updated on 2026-03-11)

Check the Beta-Sitosterol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Beta-sitosterol structurally mimics cholesterol to competitively inhibit intestinal dietary and biliary cholesterol uptake, thereby reducing sterol incorporation into cellular membranes and circulating lipoproteins. This inhibition lowers circulating total serum cholesterol and low-density lipoprotein levels, providing a mechanistic basis for its clinical investigation in hyperlipidemia and cerebrovascular conditions such as stroke.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.