Evaluating the effectiveness of Eicosapentaenoic Acid on the neurocognitive performance, length of Hospitalization and quality of life of patients with mild Traumatic Brain Injury.

Evaluating the Effectiveness of Eicosapentaenoic Acid compared to placebo on the Neurocognitive performance, Length of Hospitalization and Quality of life of Patients with mild Traumatic Brain Injury: A Randomized Controlled Trial.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170608034390N17

Enrollment

100

Registered

2025-05-04

Start date

2025-05-05

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Traumatic Brain Injury. Diffuse traumatic brain injury

Interventions

Intervention 1: Intervention group: Patients take 2 oral softgels containing 1000 mg of eicosapentaenoic acid in two divided doses, morning and evening, on a full stomach for 2 months. Intervention 2:

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 18 years Mild Traumatic Brain Injury Hospitalized in neurosurgery ward

Exclusion criteria

Exclusion criteria: Patients that are under treatment with Alteplase Patients with the history of allergy to fish liver oil and its derivatives. Patients with platelet level Count < 50,000 Patients with Hemorrhagic Peptic Ulcer Pregnancy Patients with uncontrolled diarrhea Patients under 18 years old

Design outcomes

Primary

Measure	Time frame
Score on the SF-36 Health Survey in patients. Timepoint: At the time of hospitalization, before discharge, 2 weeks after discharge and 2nd month. Method of measurement: SF-36 Health Survey.	—

Secondary

Measure	Time frame
Score in Post Concussion Symptom scale in patients. Timepoint: At the time of hospitalization, before discharge, 2 weeks after discharge and at 2nd month. Method of measurement: Post Concussion Symptom Scale.;Level of consciousness in patient. Timepoint: At the time of hospitalization, before discharge, 2 weeks after discharge and at 2nd month. Method of measurement: Glasgow Coma Scale.;Number of days of hospitalization. Timepoint: At the time of hospitalization and at the time of discharge. Method of measurement: Counting the number of days.	—

Measure

Time frame

Score in Post Concussion Symptom scale in patients. Timepoint: At the time of hospitalization, before discharge, 2 weeks after discharge and at 2nd month. Method of measurement: Post Concussion Symptom Scale.;Level of consciousness in patient. Timepoint: At the time of hospitalization, before discharge, 2 weeks after discharge and at 2nd month. Method of measurement: Glasgow Coma Scale.;Number of days of hospitalization. Timepoint: At the time of hospitalization and at the time of discharge. Method of measurement: Counting the number of days.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Esmaily

Shahid Beheshti University of Medical Sciences

Esmaily_hadi@sbmu.ac.ir+98 21 8887 3704

Outcome results

None listed

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