Safety Study of Melatonin in Stroke Patients

Not yet recruiting

Phase 4 Results N/A

Trial Description

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.

Detailed 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.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: sugar pill
    Description: sugar pill given over 14 days
  • Melatonin Drug
    Other Names: Melatonin
    Intervention Desc: none
    ARM 1: Kind: Experimental
    Label: Melatonin
    Description: Melatonin 14mg/daily given over 14 days

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement of at least one point on the MRS score 3 months No

Sponsors