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OpenTrials
Completed

NCT Number: NCT00721825

Study of NeuroAid In Enhancing Recovery After Stroke

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tan Tock Seng Rehabilitation department

Singapore, 569766

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuroAid

Drug

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

NeuroAid matched Placebo

Drug

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

Primary outcomes

  1. Fugl-Meyer assessment

    Time frame: 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Moleac Pte Ltd.

Industry

Registry information

Official study 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)

Acronym: TIERS

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 24, 2008
Registry last updated
Jul 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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