Stroke and Tocotrienol: Unique Role in Neuroprotection
NCT02263924 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2018-02-13
Summary
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Tocotrienol
Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months
- DIETARY_SUPPLEMENT
-
Placebo capsules
Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months
Sponsors & Collaborators
-
Clinical Research Centre Hospital Taiping
collaborator UNKNOWN -
Universiti Sains Malaysia
collaborator OTHER -
Seberang Jaya Clinical Research Centre
lead OTHER_GOV
Principal Investigators
-
IRENE LOOI · SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE
-
KAH HAY YUEN · Universiti Sains Malaysia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- Malaysia
Study Locations
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