Investigation of melatonin effect on outcome of moderate and severe diffuse axonal injury(DAI) in men admitted in Kerman Educational And Traputical Center Of Shahid Bahonar: changes in inflammatory, oxidant activity and injury factors

Phase 3

Conditions: diffuse axonal injury.
Unspecified focal traumatic brain injury
S06.30

Registration Number: IRCT20190717044248N6

Lead Sponsor: Kerman University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Male

Target Recruitment: 70

Inclusion Criteria

Man Gender
Age between 18 to 60
Moderate (GCS:9-12) and Sever (GCS=9) diffuse axonal injury
less than 4 hours from accident

Exclusion Criteria

Brain death
sepsis
electrolyte disorders
use of steroids
need for surgery except neurosurgery
personal dissatisfaction
high blood pressure
diabetes
metabolic acidosis (bicarbonate below 12)
liver trauma
cancer
depression
cardiovascular risk factors
Autoimmune diseases
respiratory failure
fractures
severe hypothermia (temperature less than 35 degrees Celsius)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GOSE:Standard leveling is obtained based on death, vegetative state, severe disability, low level, high level, and moderate level. Timepoint: Admit time, first month, third month and sixth month. Method of measurement: Extended- Glasgow Coma Scale.;Measurement of dependence in motor and cognitive domains where a higher score is a sign of higher recovery or less damage. Timepoint: Admit time, first month, third month and sixth month. Method of measurement: The Functional Independence Measure Scale.;Glasgow criteria is obtained based on language, verbal and motor responses. Timepoint: Admission and discharge time. Method of measurement: physical examination.

Secondary Outcome Measures