Study of NeuroAid In Enhancing Recovery After Stroke (TIERS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00721825
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : July 24, 2008
Information provided by:
Moleac Pte Ltd.

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.

Condition or disease Intervention/treatment Phase
Stroke Cerebral Infarction Drug: Neuroaid Drug: Neuroaid matched Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Study Start Date : January 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Dr Kong Keng He - senior consultant, Tan Tock Seng Hospital Identifier: NCT00721825     History of Changes
Other Study ID Numbers: Moleac
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: July 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