Study of NeuroAid In Enhancing Recovery After Stroke

Stroke Clinical Trial

— TIERS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721825
• Other study ID #: Moleac
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2008
• Last updated: July 23, 2008
• Start date: January 2008
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Moleac Pte Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Stroke

Intervention

Drug:
• Neuroaid
Neuroaid capsules, 4 capsules, three times per day, during one month
• Neuroaid matched Placebo
Neuroaid matched placebo 4 capsules three times per day during one month

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Rehabilitation department	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Moleac Pte Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer assessment		4 weeks	No
Secondary	Functional Independence Measure (FIM) scale		4 weeks and 8 weeks	No
Secondary	Fugl-Meyer subscores		4 weeks and 8 weeks	No
Secondary	NIHSS and NIHSS subscores		4 weeks and 8 weeks	No