The effect of N-acetylcysteine (NAC) in patients with moderate traumatic brain injury (MTBI)

Clinical trial to evaluate the effect of N-acetylcysteine (NAC) in patients with moderate traumatic brain injury (MTBI)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017010131709N1

Enrollment

104

Registered

2017-03-05

Start date

2017-02-19

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Traumatic brain injury. Traumatic cerebral oedema

Interventions

Intervention 1: The treatment group : Patients will receive N-acetylcysteine ( NAC) 150mg/kg in 200ml Glucose5% over a 30 minute time period. Intervention 2: The control group: Patients will receive

Treatment - Drugs

The treatment group : Patients will receive N-acetylcysteine ( NAC) 150mg/kg in 200ml Glucose5% over a 30 minute time period.

The control group: Patients will receive 200 cc serum distilled water 5% over a 30 minute time period.

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients older than 18 years old.; patients with moderate traumatic brain injury; The GCS between 9 and 13; Filling out the informed consent form by the patient or the accompanies. Exclusion criteria: Unwillingness to participate in the study; Patients who have consumed alcohol or used narcotics at anytime while diagnosed with MTBI; Patients who showed an allergic reaction to NAC

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Superoxide dismutase. Timepoint: Before treatment, six hours after the first dose. Method of measurement: Blood samples will be taken from patients and initial values of blood antioxidant enzymes: (Superoxide dismutase U/ml ) will be recorded in the checklist.;Glutathione peroxidase. Timepoint: Before treatment, six hours after the first dose. Method of measurement: Blood samples will be taken from patients and initial values of blood antioxidant enzymes: (Glutathione peroxidase U/l ) will be recorded in the checklist.	—

Measure

Time frame

Superoxide dismutase. Timepoint: Before treatment, six hours after the first dose. Method of measurement: Blood samples will be taken from patients and initial values of blood antioxidant enzymes: (Superoxide dismutase U/ml ) will be recorded in the checklist.;Glutathione peroxidase. Timepoint: Before treatment, six hours after the first dose. Method of measurement: Blood samples will be taken from patients and initial values of blood antioxidant enzymes: (Glutathione peroxidase U/l ) will be recorded in the checklist.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Gharibi

Arak University of Medical Sciences

morteza.qaribi@gmail.com+98 912 633 0676

Outcome results

None listed

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