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Cerebroprotective Effect of Melatonin in Stroke

NCT05857046 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-05

No results posted yet for this study

Summary

Stroke is a leading cause of mortality and disability in Mexico and worldwide. Although current treatment strategies focus on removing oclussion, they do not interrupt the signaling cascade of neuronal damage. Thus, the search for a cerebroprotective agent that can protect the entire brain. Melatonin has been proposed as a potential cerebroprotective agent due to its antioxidant, anti-inflammatory, antiapoptotic, and immunomodulatory effects, which oppose the pathophysiological mechanisms of cerebrovascular disease. Melatonin has the potential to improve stroke outcomes and reduce the risk of disability and mortality, making it a promising therapeutic option for stroke patients.

To assess the efficacy of melatonin in patients with acute ischemic CVD, improve clinical outcome, and infarct volume.

Conditions

  • Stroke, Acute Ischemic
  • Strokes Thrombotic

Interventions

DRUG

Melatonin 10 MG

Patients received extended-release melatonin 10 mg PO every 12 hours for 7 days and then every 24 hours for 83 days

OTHER

Placebo

Patients received placebo every 12 hours for 7 days and then every 24 hours for 83 days

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Universidad Michoacana de San Nicolás de Hidalgo

    collaborator UNKNOWN

  • Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

    collaborator OTHER_GOV

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Georgina Ortiz-Martínez, MC · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-03-15
Completion
2025-07-14

Countries

  • Mexico

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 NCT05857046 on ClinicalTrials.gov