Phase III, single-centre, double-blind, randomised, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of oral Vitamin E (Mixed Tocotrienol) for 6 months in patients with moderate ischemic stroke. 150 patients will be recruited and randomized to receive either placebo or mixed tocotrienol 200mg twice a day for 6 months. Patients will be followed up and assessed on their functional recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months
Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months
Seberang Jaya Clinical Research Centre
Seberang Jaya, Pulau Pinang, Malaysia
RECRUITINGModified Rankin Score
Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)
Time frame: 6th Month
Modified Rankin Score
Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio)
Time frame: 3rd month
Modified Barthel Index
• Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment)
Time frame: 6th months
NIHSS
Reduction in NIHSS at the end of 6 months of treatment from baseline
Time frame: before dosing and at 6th month
Composite score (MRS, NIHSS, mBI)
Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS \<6, and mBI at least 95
Time frame: 6th month
Modified Rankin Score
Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 3 months of treatment
Time frame: 3rd month
Modified Rankin Score
Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment
Time frame: 6th month
MRI - Brain lesion volume
Change in stroke lesion volume
Time frame: 6th month
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SF-36
quality of life
Time frame: 6th month
CLOX and TMT Parts A & B
Improvement in the score of CLOX and TMT Parts A \& B at the end of 24-weeks of treatment from baseline
Time frame: 6th month
Adverse event monitoring
Adverse event outcomes in both groups
Time frame: 6 months