Safety Study of Melatonin in Stroke Patients

Wolfson Medical Center140 enrolled

Overview

The purpose of the study is to evaluate the effect of Melatonin (in a dosage of 14mg daily) for a better clinical outcome in the period three days post stroke.

Stroke is the third most common cause of stroke. The cascade of event is separated into hyperacute,,acute,sub-acute and chronic. In the acute, sub acute state there are mechanisms of inflammation apoptotic death and effect of free radicals. Melatonin was proved to effect these mechanisms and to have a favourable effect in different diseases. The aim of the study is to prove That the use of Melatonin in a higher dosage may have a anti-destructive effect in stoke.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

140

Conditions

Acute Ischemic Stroke

Interventions

MelatoninDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * within 72hours of ischemic stroke * age 18-80 * both gender * ability to sign consent form Exclusion Criteria: * intra-cerebral bleeding * tumour of brain * multiple sclerosis * s/p craniotomy * known allergy to melatonin

Locations (1)

E. Wolfson Medical Center

Holon, Israel

Outcomes

Primary Outcomes

Improvement of at least one point on the MRS score

Time frame: 3 months

Data from ClinicalTrials.gov

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