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CHInese Medicine NeuroAid Efficacy on Stroke Recovery (CHIMES)

This study has been completed.
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
CHIMES Society
ClinicalTrials.gov Identifier:
NCT00554723
First received: November 5, 2007
Last updated: April 30, 2014
Last verified: April 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:
  • NIHSS, Barthel Index, MMSE [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 1100
Study Start Date: May 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
NeuroAid
Drug: NeuroAid
4 capsules 3 times daily, for three months
Other Name: Danqi Piantan Jiaonang (In China)
Placebo Comparator: B
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 increase stroke patients'recovery in terms of neurological disability and functional outcome{Chen et al,2009}and thus may be beneficial as part of a post-stroke rehabilitation programme.

In the CHIMES study,we seek to test the hypothesis that NeuroAiD is superior to a placebo in reducing neurological deficit and improving functional outcome in patients recruited within 72 h after the ischemic stroke with intermediate range of severity {6<_NIHSS<_14}.More details of the study protocol have recently been published {Venketasubramanian et al,2009}.

  Eligibility

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

Inclusion Criteria:

  • Subject is aged 18 years old and above (for Singapore 21 years and above as this is the legal age of consent)
  • 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 72 hours after symptoms onset
  • Subject with cerebral infarction with intermediate severity range: 6 ≤ NIHSS ≤ 14

Exclusion Criteria:

  • Subjects deemed unstable by investigator after thrombolysis treatment
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Malaysia
Penang General Hospital
Georgetown, Penang, Malaysia, 10990
Philippines
Visayas Community Medical Center
Cebu City, Cebu, Philippines, 6000
Baguio General Hospital and Medical Center
Baguio City, Philippines, 2600
Chong Hua Hospital
Cebu, Philippines
Brokenshire Hospital
Davao, Philippines
Davao Medical Center
Davao, Philippines, 8000
Davao Medical School Foundation
Davao, Philippines
West Visayas State University Hospital
Iloilo City, Philippines, 5000
Jose Reyes Memorial Medical Center
Manila, Philippines, 1003
Philippine General Hospital
Manila, Philippines
University of Santo Tomas
Manilla, Philippines, 1008
Singapore
National University Hospital
Singapore, Singapore, 119074
National Neuroscience Institute - Tan Tock Seng Campus
Singapore, Singapore, 308433
Changi General Hospital
Singapore, Singapore, 529889
Singapore General Hospital
Singapore, Singapore, 308433
Sri Lanka
University of Kelaniya
Ragama, Sri Lanka
Thailand
Chiangmai University Hospital
Muang City, Chiangmai, Thailand, 50200
Thammasart Hospital
Bangkok, Thailand, 12121
King Mongkutla Hospital
Bangkok, Thailand
Prasat Neurological Institute
Bangkok, Thailand, 10400
Rajvithee Hospital
Bangkok, Thailand, 10400
Siriraj Hospital
Bangkok, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CHIMES Society
ClinicalTrials.gov Identifier: NCT00554723     History of Changes
Other Study ID Numbers: SQSTR03 - CHIMES
Study First Received: November 5, 2007
Last Updated: April 30, 2014
Health Authority: Singapore: Health Sciences Authority
Singapore: Domain Specific Review Boards
Philippines: Bureau of Food and Drugs
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Hong Kong: Department of Health
Thailand: Food and Drug Administration
Thailand: Ministry of Public Health
Malaysian: Malaysian Research Ethics Committee

Keywords provided by CHIMES Society:
Stroke
Cerebral infarct
Recovery
Double blind
Randomized
Placebo
Traditional Chinese Medicine
Neuroaid

Additional relevant MeSH terms:
Cerebral Infarction
Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014