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Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke

NCT06777680 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-16

No results posted yet for this study

Summary

Acute ischemic stroke is caused by reduced blood supply to the brain associated with neuroinflammation. This mechanism contributes to acute neuronal death and persists even after reopening of the closed vessel, with consequent limitation of clinical and functional improvement.

Experimental and clinical evidence demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultramicronized Palmitoylethanolamide (PEA).

The aim of this study is to evaluate the effect of co-ultramicronized PEA and luteolin (700 mg + 70 mg in 10 ml) on the clinical outcomes of patients with acute ischemic stroke undergoing mechanical thrombectomy.

Conditions

  • Acute Ischemic Stroke AIS

Interventions

DIETARY_SUPPLEMENT

co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)

oral suspension, 10 ml twice a day (every 12 hours) for 7 days

OTHER

Placebo

oral suspension,10 ml twice a day (every 12 hours) for 7 days

PROCEDURE

Thrombectomy

Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines

Sponsors & Collaborators

  • Ospedali Riuniti Trieste

    lead OTHER

Principal Investigators

  • Marcello Naccarato, MD, PhD · Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06777680 on ClinicalTrials.gov