Study of NeuroAid In Enhancing Recovery After Stroke (TIERS)

July 23, 2008 updated by: Moleac Pte Ltd.

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 569766
        • Tan Tock Seng Rehabilitation department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Neuroaid
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer assessment
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moleac Pte Ltd.

Investigators

  • Principal Investigator: Keng He Kong, MD, Tan Tock Seng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

July 22, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (Estimate)

July 24, 2008

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Moleac

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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