Cerebral Infarction, Stroke
Conditions
Keywords
Stroke, Cerebral infarct, Rehabilitation, Double blind Randomized, Placebo controlled, Traditional Chinese Medicine, Neuroaid
Brief summary
TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used.
Interventions
DRUGNeuroaid
Neuroaid capsules, 4 capsules, three times per day, during one month
Neuroaid matched placebo 4 capsules three times per day during one month
Sponsors
Moleac Pte Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject had cerebral infarction confirmed by Computed Tomography (CT scan or Magnetic Resonance Imaging (MRI) imaging * Presents within 1 month after stroke onset * Presents with motor power of from grade 1 - 4/5 in at least one limb * Has a pre-stroke modified Rankin score ≤ 1. * Age between 21 and 80 years old * Female subjects are eligible to participate in the trial if they are of non childbearing potential (hysterectomy or post-menopausal) * Subject or legally acceptable representative is willing and able to provide written informed consent * Subject and carer are willing and able to comply with investigational drug administration schedule.
Exclusion criteria
* Subject has received thrombolysis * Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI * Subject has definite indication for full-dose or long-term anticoagulation therapy * Subject has other significant non-ischemic brain lesion which could affect function disability * Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine \>200 μmol/L, if known), cirrhosis, severe dementia or psychosis * Subject has a history of previous stroke/s * Subject has participated in another clinical trial within the last three months * Subject has aphasia or any other cognitive disabilities which prevent cooperation with study instructions * Subject has dense hemiplegia (grade 0 motor power) * Subject has haemoglobin level of \<10mg/dl on admission * Subject has a history of craniotomy or seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer assessment | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Functional Independence Measure (FIM) scale | 4 weeks and 8 weeks |
| Fugl-Meyer subscores | 4 weeks and 8 weeks |
| NIHSS and NIHSS subscores | 4 weeks and 8 weeks |
Countries
Singapore
Outcome results
None listed