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Study of NeuroAid In Enhancing Recovery After Stroke

NCT ID: NCT00721825

Last Updated: 2008-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Cerebral Infarction

Keywords

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Stroke Cerebral infarct Rehabilitation Double blind Randomized Placebo controlled Traditional Chinese Medicine Neuroaid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Neuroaid

Group Type ACTIVE_COMPARATOR

Neuroaid

Intervention Type DRUG

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

2

Neuroaid matched placebo

Group Type PLACEBO_COMPARATOR

Neuroaid matched Placebo

Intervention Type DRUG

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

Interventions

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Neuroaid

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

Intervention Type DRUG

Neuroaid matched Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moleac Pte Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Tan Tock Seng Hospital

Principal Investigators

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Keng He Kong, MD

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

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Tan Tock Seng Rehabilitation department

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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Moleac

Identifier Type: -

Identifier Source: org_study_id