Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinical Research Centre Hospital Taiping | UNKNOWN |
| Universiti Sains Malaysia | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocotrienol | Dietary Supplement | Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Score | Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio) | 6th Month |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Score | Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio) | 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) |
Not provided
Adult patients within 1-10 days ischaemic stroke of moderate severity (NIHSS 6-20)
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| IRENE LOOI | Contact | irenelooi@yahoo.com | ||
| WEN YAO MAK | Contact | makwenyao@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| IRENE LOOI | SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE | Principal Investigator |
| KAH HAY YUEN | Universiti Sains Malaysia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seberang Jaya Clinical Research Centre | Recruiting | Seberang Jaya | Pulau Pinang | 13700 | Malaysia |
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D024508 | Tocotrienols |
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Patients will be randomized to receive either placebo or investigational drug (mixed tocotrienols dietary supplement) for 6 months.
Not provided
Not provided
Not provided
| Placebo capsules | Dietary Supplement | Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months |
|
| 6th months |
| NIHSS | Reduction in NIHSS at the end of 6 months of treatment from baseline | 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 | 6th month |
| Modified Rankin Score | Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 3 months of treatment | 3rd month |
| Modified Rankin Score | Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment | 6th month |
| MRI - Brain lesion volume | Change in stroke lesion volume | 6th month |
| SF-36 | quality of life | 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 | 6th month |
| Adverse event monitoring | Adverse event outcomes in both groups | 6 months |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |