Trial | NCT00721825  Report issue

Title

Study of NeuroAid In Enhancing Recovery After Stroke
A Double-Blinded, Placebo-Controlled, Randomized Phase II Pilot Study to Investigate the Potential Efficacy of a Traditional Chinese Medicine NeuroAid In Enhancing Recovery After Stroke (TIERS)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    neuroaid ...

  • Study Participants

    40
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.
Study Started
Jan 31
2008
Primary Completion
Jul 31
2008
Study Completion
Jul 31
2008
Last Update
Jul 24
2008
Estimate

Drug Neuroaid

Neuroaid capsules, 4 capsules, three times per day, during one month

Drug Neuroaid matched Placebo

Neuroaid matched placebo 4 capsules three times per day during one month

1 Active Comparator

Neuroaid

2 Placebo Comparator

Neuroaid matched placebo

Criteria 

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
No Results Posted