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Study of NeuroAid In Enhancing Recovery After Stroke (TIERS)

This study has been completed.
Information provided by:
Moleac Pte Ltd. Identifier:
First received: July 22, 2008
Last updated: July 23, 2008
Last verified: July 2008
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.

Condition Intervention Phase
Stroke Cerebral Infarction Drug: Neuroaid Drug: Neuroaid matched Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Moleac Pte Ltd.:

Primary Outcome Measures:
  • Fugl-Meyer assessment [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Functional Independence Measure (FIM) scale [ Time Frame: 4 weeks and 8 weeks ]
  • Fugl-Meyer subscores [ Time Frame: 4 weeks and 8 weeks ]
  • NIHSS and NIHSS subscores [ Time Frame: 4 weeks and 8 weeks ]

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: Neuroaid
Neuroaid capsules, 4 capsules, three times per day, during one month
Placebo Comparator: 2
Neuroaid matched placebo
Drug: Neuroaid matched Placebo
Neuroaid matched placebo 4 capsules three times per day during one month


Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00721825

Tan Tock Seng Rehabilitation department
Singapore, Singapore, 569766
Sponsors and Collaborators
Moleac Pte Ltd.
Principal Investigator: Keng He Kong, MD Tan Tock Seng Hospital
  More Information

Responsible Party: Dr Kong Keng He - senior consultant, Tan Tock Seng Hospital Identifier: NCT00721825     History of Changes
Other Study ID Numbers: Moleac
Study First Received: July 22, 2008
Last Updated: July 23, 2008

Keywords provided by Moleac Pte Ltd.:
Cerebral infarct
Double blind Randomized
Placebo controlled
Traditional Chinese Medicine

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia processed this record on August 16, 2017