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Effect of Melatonin in brain injury

Phase 3
Recruiting
Conditions
Brain injury.
Intracranial injury
Registration Number
IRCT20081208001497N8
Lead Sponsor
Esfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

Adult patients (age more than 18) who had traumatic brain injury included skull fracture, subdural hemorrhage, subarachnoid hemorrhage, brain contusion and laceration, intracerebral hemorrhage, intraventricular hemorrhage and traumatic axonal injury
Non-traumatic brain injury included strokes, infections, hypoxia and brain tumors
Admission within 72 hours after brain injury in intensive care unit or other wards such as neurology or neurosurgery
Healthy gastrointestinal tract (capable of oral ingestion or gavage of drug)

Exclusion Criteria

Length of hospitalization less than 5 days in intensive care units or other wards
Hypersensitivity to melatonin
Hepatic failure (class C according to Child-pugh)
Renal failure (need dialysis)
Severe heart failure (Class 3 and 4 according to Newyork heart association)
Sepsis within first 5 days of admission

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in bio markers of mitochondrial injury. Timepoint: Day 1 and 5 of intervention. Method of measurement: Elisa kit.
Secondary Outcome Measures
NameTimeMethod
Mortality rate of patients. Timepoint: 28 days. Method of measurement: Observation.
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