Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules three times per day over 6 months. Evaluation of patients will be carried out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be evaluated by comparing these two scores between the 2 groups at follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months
Brain Mapping Research Center
Tehran, Iran
RECRUITINGfunctional outcome 1
functional outcome scales of GOS
Time frame: at baseline
functional outcome 2
functional outcome scales of GOS
Time frame: at 3rd month post-injury
functional outcome 3
functional outcome scales of GOS
Time frame: at 6th month post-injury
functional outcome 4
functional outcome scales of MRS
Time frame: at baseline
functional outcome 5
functional outcome scales of MRS
Time frame: at 3rd month post-injury
functional outcome 6
functional outcome scales of MRS
Time frame: at 6th month post-injury
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