Diffuse traumatic brain injury. Diffuse traumatic brain injury
Conditions
Interventions
Intervention 1: Intervention group:dimethyl fumarate, 240 mg daily for 21 days. Abidi Pharmaceuticals (Iran). Intervention 2: Control group: Placebo, 240 mg daily for 21 days.
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 50 years Consent to participate in the study Diffuse axonal injury Glasgow Coma Scale = 8
Exclusion criteria
Exclusion criteria: Unwillingness of the patient's first-degree relative to participate in the study Any blood disease or history of it Brain death Severe cerebrovascular or carotid disease History of drug allergy Hemorrhagic brain injury due to trauma Infection during hospitalization Multiple Trauma cases Patients with liver disease Patients with kidney disease Patients with a history of infection or a weak immune system Pregnant and breastfeeding mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glasgow Outcome Scale. Timepoint: 3 months and 6 months after intervention. Method of measurement: Standard clinical scale.;Glasgow Coma Scale. Timepoint: 3 months and 6 months after intervention. Method of measurement: Standard clinical scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Malondialdehyde level. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Laboratory kit.;Total antioxidant capacity. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Laboratory kit.;Interleukin 6. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Laboratory kit.;Calcium. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Laboratory kit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeid Ehteshami ??? ???? ???????:
Mazandaran University of Medical Sciences
Outcome results
None listed