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

Investigation of melatonin effect on the 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190717044248N6

Enrollment

Registered

2023-03-19

Start date

2022-10-22

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diffuse axonal injury. Unspecified focal traumatic brain injury

Interventions

Intervention 1: Intervention group: including 35 participants with diffuse axonal injury, each patient received 3 mg of melatonin (Razak Company) manufactured in Iran upon admission time and from the

Eligibility

Sex/Gender

Male

Age

18 Years to 60 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
IL-1ß. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;Serum melatonin level. Timepoint: Twice a day in the first 24 hours after the injury, once every 12 hours, and twice on the fifteenth day after the injury, once every 12 hours, and twice on the last day of use, once every 12 hours (6 times in total). Method of measurement: Using the relevant kit.;IL-10. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;IL6MDA. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;Pyridyl triazine. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;Nerve growth factor. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;Thiobarbituric acid. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;S100B-Protean. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.	—

Measure

Time frame

IL-1ß. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;Serum melatonin level. Timepoint: Twice a day in the first 24 hours after the injury, once every 12 hours, and twice on the fifteenth day after the injury, once every 12 hours, and twice on the last day of use, once every 12 hours (6 times in total). Method of measurement: Using the relevant kit.;IL-10. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;IL6MDA. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;Pyridyl triazine. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;Nerve growth factor. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;Thiobarbituric acid. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.;S100B-Protean. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Ghaedamini

Kerman University of Medical Sciences

alirezaghaedamini@gmail.com+98 34 3434 0454

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026