Title

Stroke and Tocotrienol: Unique Role in Neuroprotection
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 Acute Ischemic Stroke
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Unknown status
  • Intervention/Treatment

    tocotrienol ...
  • Study Participants

    150
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 Started
Jul 31
2015
Primary Completion
Dec 31
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Feb 13
2018

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

Experimental: Tocotrienol Experimental

Mixed tocotrienol 200mg twice a day for 6 months

Placebo (for tocotrienol) Placebo Comparator

Placebo capsules, 1 capsule twice a day for 6 months

Criteria

Adult patients within 1-10 days ischaemic stroke of moderate severity (NIHSS 6-20)

Inclusion Criteria:

Age 35 years old and above.
Subject will be included within the time frame of 1-10 days after the first onset of acute cerebral ischaemic stroke with NIHSS between 6 - 20.
Subject is neurologically stable after stroke onset, i.e. no fluctuation in clinical conditions.
Subject has a modified Rankin Scale from 2-4.
Subject has a clinical stroke diagnosis according to WHO stroke diagnosis.
Subject is willing to attend at least four sessions of physiotherapy during the study or as deemed needed by the physiotherapist
Subjects or his/her legally acceptable representative is willing to provide written informed consent.

Exclusion Criteria:

Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
Recurrent stroke or previous hospitalisation due to suspected cerebrovascular event.
Severe stroke as assessed clinically and/or by appropriate imaging techniques
Subject has other significant non-ischemic brain lesion(s) which could affect function or disability.
Time of ischemic stroke onset not exactly known
Subject has documented underlying medical conditions which may affect assessment or follow-up such as (but not limited to) terminal cancer, liver cirrhosis, severe dementia or psychosis, connective tissue disease, rheumatoid arthritis, severe heart disease, severe liver disease or renal failure (based on recent medical history)
Subject has active systemic infection such as (but not limited to) hepatitis and pneumonia
Subject has definite indication for full dose or long term anti-coagulation therapy (such as warfarin)
Any condition that in the judgment of the investigator would place the patient under undue risk
Traumatic brain injury within the previous 30 days.
Symptoms which are rapidly improving (as in transient ischemic stroke)
The patient is pregnant, breast feeding or female of childbearing potential (unless the subject is willing to practice on double contraception measures for the study duration) until up to 1 month (30 days) after last treatment dose.
Patients who have been included in any other clinical trial within the previous three months.
No Results Posted