Safety Study of Melatonin in Stroke Patients

Wolfson Medical Center (WMC)

Status and phase: Unknown; Phase 4

Conditions: Acute Ischemic Stroke

Treatments: Drug: placebo; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01863277

0130-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Melatonin

Active Comparator group

Description:

Melatonin 14mg/daily given over 14 days

Treatment:

Drug: Melatonin

sugar pill

Placebo Comparator group

Description:

sugar pill given over 14 days

Treatment:

Drug: placebo