CHInese Medicine NeuroAid Efficacy on Stroke Recovery - Full Text View

Sponsors and Collaborators:	CHIMES Society National Medical Research Council (NMRC), Singapore
Information provided by:	CHIMES Society
ClinicalTrials.gov Identifier:	NCT00554723

Purpose

CHIMES is a double blind, placebo controlled, randomized, multicenter study to test the hypothesis that NeuroAid is superior to placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction of an intermediate range of severity.

Condition	Intervention	Phase
Cerebral Infarction Stroke	Drug: NeuroAid Drug: Neuroaid matched Placebo	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double Blind, Placebo Controlled, Randomized, Multicenter Study to Investigate CHInese Medicine NeuroAid Efficacy on Stroke Recovery

Further study details as provided by CHIMES Society:

Primary Outcome Measures:

Distribution modified Rankin Scale grades for all randomized subjects [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

NISS, Barthel Index, MMSE [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1100
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental NeuroAid	Drug: NeuroAid 4 capsules 3 times daily, for three months
B: Placebo Comparator Neuroaid matched Placebo	Drug: Neuroaid matched Placebo NeuroAid matched Placebo, 4 capsules 3 times daily, for three months

Detailed Description:

Stroke is a major cause of death and disability. Previous clinical studies performed in China have shown that NeuroAid, a Traditional Chinese Medicine, increases stroke patients' recovery from their neurological disability and functional outcome and thus, may be beneficial in post stroke rehabilitation.

CHIMES trials aim at measuring the efficacy of NeuroAid using Western clinical trials methodology. Positive results from such a trial will establish clearly in Western medicine the potential of NeuroAid and support the awareness of such treatment's availability in the medical and patient communities.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is aged 21 years old and above
Subject is on anti-platelet therapy
Subject is presented a pre-stroke Modified Rankin Scale inferior or equal to 1
Female subject is eligible to participate in the trial if she is of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post menopausal)
Subject or his/her legally acceptable representative is willing to provide written informed consent
Subject is presented with cerebral infarction with compatible imaging at Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI)
Time window is less than 48 hours after symptoms onset
Subject with cerebral infarction with intermediate severity range: 6 ≤ NIHSS ≤ 14

Exclusion Criteria:

Subject has received thrombolysis
Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
Subject has a rapidly improving neurological deficit
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 participated in another clinical trial within the last three months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554723

Contacts

Contact: Christopher LH Chen, MD	+6563265003 ext xx	phccclh@nus.edu.sg
Contact: David J. Picard, MD	+6564789430 ext 1	david-picard@chimes-society.org

Locations

Philippines
University of Santo Tomas	Recruiting
Manilla, Philippines, 1008
Contact: Josee C. Navarro, MBBS 0632 731 3042 josen@pldtdsl.net
Principal Investigator: Jose C. Navarro, MBBS
Sub-Investigator: Alejandro II Baroque, MBBS
Jose Reyes Memorial Medical Center	Recruiting
Manila, Philippines, 1003
Contact: Herminigildo Gan gilganmd@yahoo.com
Contact: Maidy Arguelles ymidarguelles021@yahoo.com
Principal Investigator: Herminigildo Gan
Sub-Investigator: Maidy Arguelles
Davao Medical Center	Recruiting
Davao, Philippines, 8000
Contact: Annabelle Lao aylmd@yahoo.com
Principal Investigator: Annabelle Lao
Singapore
National Neuroscience Institute - Tan Tock Seng Campus	Recruiting
Singapore, Singapore, 308433
Contact: N. V. Ramani, MBBS M Med +6563577176 ramani_nv@nni.com.sg
Contact: Robet N. Gan, MD +6563577171 Robert_Gan@nni.com.sg
Principal Investigator: N. V. Ramani
Sub-Investigator: Robert Gan
Singapore General Hospital	Recruiting
Singapore, Singapore, 308433
Contact: Hui Meng Chang, MBBS chang.hui.meng@sgh.com.sg
Contact: Dao Juan LIM lim.dao.juan@sgh.com.sg
Principal Investigator: Hui Meng Chang, MBBS
National University Hospital	Recruiting
Singapore, Singapore, 119074
Contact: Bernard PL Chan, MBBS +656772 4121 Bernard_CHAN@nuh.com.sg
Contact: Lily Wong Lily_WONG@nuh.com.sg,
Principal Investigator: Bernard PL Chan, MBBS
Changi General Hospital	Recruiting
Singapore, Singapore, 529889
Contact: N. V. Ramani, MBBS +65 63577176 ramani_nv@nni.com.sg
Contact: Lay Hwa +65 68502375 Lay_Hwa_Yew@cgh.com.sg
Principal Investigator: N. Venketasubramanian Ramani, MBBS
Sub-Investigator: Robert Gan, MMBS

Sponsors and Collaborators

CHIMES Society

National Medical Research Council (NMRC), Singapore

Investigators

Study Director:	Marie Germaine Bousser, MD	APHP Paris
Principal Investigator:	Christopher Chen, MBBS	National University, Singapore

More Information

Responsible Party:	National University of Singapore ( Dr Christopher Chen )
Study ID Numbers:	SQSTR03 - CHIMES
Study First Received:	November 5, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00554723
Health Authority:	Singapore: Health Sciences Authority; Philippines: Bureau of Food and Drugs

Keywords provided by CHIMES Society:

Stroke
Cerebral infarct
Recovery
Double blind

Randomized
Placebo
Traditional Chinese Medicine
Neuroaid

Study placed in the following topic categories:

Necrosis
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia

Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009