CHInese Medicine NeuroAid Efficacy on Stroke Recovery (CHIMES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00554723
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : May 1, 2014
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
CHIMES Society

Brief Summary:
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 or disease Intervention/treatment Phase
Cerebral Infarction Stroke Drug: NeuroAid Drug: NeuroAid matched Placebo Phase 3

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}.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2007
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: A
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

Primary Outcome Measures :
  1. Distribution modified Rankin Scale grades for all randomized subjects [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. NIHSS, Barthel Index, MMSE [ Time Frame: 3 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00554723

Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Penang General Hospital
Georgetown, Penang, Malaysia, 10990
Visayas Community Medical Center
Cebu City, Cebu, Philippines, 6000
Baguio General Hospital and Medical Center
Baguio City, Philippines, 2600
Chong Hua Hospital
Cebu, Philippines
Davao Medical Center
Davao, Philippines, 8000
Brokenshire Hospital
Davao, Philippines
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
National University Hospital
Singapore, Singapore, 119074
National Neuroscience Institute - Tan Tock Seng Campus
Singapore, Singapore, 308433
Singapore General Hospital
Singapore, Singapore, 308433
Changi General Hospital
Singapore, Singapore, 529889
Sri Lanka
University of Kelaniya
Ragama, Sri Lanka
Chiangmai University Hospital
Muang City, Chiangmai, Thailand, 50200
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Prasat Neurological Institute
Bangkok, Thailand, 10400
Rajvithee Hospital
Bangkok, Thailand, 10400
Thammasart Hospital
Bangkok, Thailand, 12121
King Mongkutla Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Sponsors and Collaborators
CHIMES Society
National Medical Research Council (NMRC), Singapore
Study Director: Marie Germaine Bousser, MD APHP Paris
Principal Investigator: Christopher Chen, MBBS National University, Singapore

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: CHIMES Society Identifier: NCT00554723     History of Changes
Other Study ID Numbers: SQSTR03 - CHIMES
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by CHIMES Society:
Cerebral infarct
Double blind
Traditional Chinese Medicine

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