Assessment of the NeuroAid-II induced effects on Cognitive disorders in mild traumatic brain injury

Phase 3

Conditions: Mild traumatic brain injury.
Diffuse traumatic brain injury
S06.2

Registration Number: IRCT20231007059639N1

Lead Sponsor: Alborz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 238

Inclusion Criteria

A patient with a mild closed traumatic head injury.
The age group is between 18 and 55 years.
A patient with less than 3 unit decrease in the Glasgow coma score.
A patient who is a candidate for non-surgical and conservative treatment.
The patient must have written ethical consent to participate in the study.

Exclusion Criteria

Any time during the study the patient needs surgical intervention.
A patient has pupils that don't respond bilaterally to light.
A patient who has spinal cord injury at the same time.
A patient with a history of previous craniotomy (surgery for hematoma or tumor resection).
A patient with a history of cancer.
A patient who had Cardiovascular arrest during initial treatment.
A patient with a life-threatening condition.
A patient with a history of cognitive disorders, dementia, or mental illness in history
A patient who desires to withdraw from the trial at any time.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score of the Rivermead Post Concussion Symptoms Questionnaire. Timepoint: At the beginning of the study, 1 and 3 months later. Method of measurement: The Rivermead Post Concussion Symptoms Questionnaire.;Age. Timepoint: At the beginning of the study, 1 and 3 months later. Method of measurement: Patient medical history.;Gender. Timepoint: At the beginning of the study, 1 and 3 months later. Method of measurement: Patient medical history.;Underlying disease. Timepoint: At the beginning of the study, 1 and 3 months later. Method of measurement: Patient medical history.;Study group. Timepoint: After analyzing the data. Method of measurement: Naming by the researcher into two groups A and B.

Secondary Outcome Measures