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

Assessment of the NeuroAid-II induced effects on Cognitive disorders in mild traumatic brain injury in the first-month and third-month post-injury

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231007059639N1

Enrollment

238

Registered

2023-10-11

Start date

2023-10-17

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Mild traumatic brain injury. Diffuse traumatic brain injury

Interventions

Intervention 1: Intervention group: This group is treated with MLC-901(Neuro Aid II) and the usual treatment. The treatment is taking 2 capsules (0.4 grams per capsule) every 8 hours for 3 months, and

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYousefi, Pooyan

Alborz University of Medical Sciences

pooyan_y@yahoo.com+98 21 8884 5778

Outcome results

None listed

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