Study Results
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Basic Information
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COMPLETED
PHASE3
1100 participants
INTERVENTIONAL
2007-05-31
2012-08-31
Brief Summary
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Detailed Description
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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}.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
NeuroAid
NeuroAid
4 capsules 3 times daily, for three months
B
NeuroAid matched Placebo
NeuroAid matched Placebo
NeuroAid matched Placebo, 4 capsules 3 times daily, for three months
Interventions
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NeuroAid
4 capsules 3 times daily, for three months
NeuroAid matched Placebo
NeuroAid matched Placebo, 4 capsules 3 times daily, for three months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Medical Research Council (NMRC), Singapore
OTHER_GOV
CHIMES Society
OTHER
Responsible Party
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Principal Investigators
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Marie Germaine Bousser, MD
Role: STUDY_DIRECTOR
APHP Paris
Christopher Chen, MBBS
Role: PRINCIPAL_INVESTIGATOR
National University of Singapore
Locations
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Prince of Wales Hospital
Hong Kong, , Hong Kong
Penang General Hospital
George Town, Pulau Pinang, Malaysia
Visayas Community Medical Center
Cebu City, Cebu, Philippines
Baguio General Hospital and Medical Center
Baguio City, , Philippines
Chong Hua Hospital
Cebu, , Philippines
Davao Medical Center
Davao City, , Philippines
Brokenshire Hospital
Davao City, , Philippines
Davao Medical School Foundation
Davao City, , Philippines
West Visayas State University Hospital
Iloilo City, , Philippines
Jose Reyes Memorial Medical Center
Manila, , Philippines
University of Santo Tomas
Manila, , Philippines
Philippine General Hospital
Manila, , Philippines
National University Hospital
Singapore, Singapore, Singapore
National Neuroscience Institute - Tan Tock Seng Campus
Singapore, Singapore, Singapore
Singapore General Hospital
Singapore, Singapore, Singapore
Changi General Hospital
Singapore, Singapore, Singapore
University of Kelaniya
Ragama, , Sri Lanka
Chiangmai University Hospital
Muang City, Chiangmai, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Prasat Neurological Institute
Bangkok, , Thailand
Rajvithee Hospital
Bangkok, , Thailand
Thammasart Hospital
Bangkok, , Thailand
King Mongkutla Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Countries
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References
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Young SH, Zhao Y, Koh A, Singh R, Chan BP, Chang HM, Venketasubramanian N, Chen C; CHIMES Investigators. Safety profile of MLC601 (Neuroaid) in acute ischemic stroke patients: A Singaporean substudy of the Chinese medicine neuroaid efficacy on stroke recovery study. Cerebrovasc Dis. 2010;30(1):1-6. doi: 10.1159/000313398. Epub 2010 Apr 16.
Chen C, Venketasubramanian N, Gan RN, Lambert C, Picard D, Chan BP, Chan E, Bousser MG, Xuemin S. Danqi Piantang Jiaonang (DJ), a traditional Chinese medicine, in poststroke recovery. Stroke. 2009 Mar;40(3):859-63. doi: 10.1161/STROKEAHA.108.531616. Epub 2009 Jan 22.
Gan R, Lambert C, Lianting J, Chan ES, Venketasubramanian N, Chen C, Chan BP, Samama MM, Bousser MG. Danqi Piantan Jiaonang does not modify hemostasis, hematology, and biochemistry in normal subjects and stroke patients. Cerebrovasc Dis. 2008;25(5):450-6. doi: 10.1159/000126919. Epub 2008 Apr 16.
Venketasubramanian N, Chen CL, Gan RN, Chan BP, Chang HM, Tan SB, Picard D, Navarro JC, Baroque AC 2nd, Poungvarin N, Donnan GA, Bousser MG; CHIMES Investigators. A double-blind, placebo-controlled, randomized, multicenter study to investigate CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES Study). Int J Stroke. 2009 Feb;4(1):54-60. doi: 10.1111/j.1747-4949.2009.00237.x.
Chen CLH, Chai JH, Pokharkar YM, Venketasubramanian N. Cost-effectiveness of MLC601 in post-stroke functional recovery compared with placebo - the CHIMES & CHIMES-E studies. BMC Health Serv Res. 2024 Sep 27;24(1):1127. doi: 10.1186/s12913-024-11618-4.
Lee CF, Venketasubramanian N, Wong KS, Chen CL; CHIMES Study Investigators. Comparison Between the Original and Shortened Versions of the National Institutes of Health Stroke Scale in Ischemic Stroke Patients of Intermediate Severity. Stroke. 2016 Jan;47(1):236-9. doi: 10.1161/STROKEAHA.115.011657. Epub 2015 Dec 1.
Chen CL, Venketasubramanian N, Lee CF, Wong KS, Bousser MG; CHIMES Study Investigators. Effects of MLC601 on early vascular events in patients after stroke: the CHIMES study. Stroke. 2013 Dec;44(12):3580-3. doi: 10.1161/STROKEAHA.113.003226. Epub 2013 Oct 17.
Chen CL, Young SH, Gan HH, Singh R, Lao AY, Baroque AC 2nd, Chang HM, Hiyadan JH, Chua CL, Advincula JM, Muengtaweepongsa S, Chan BP, de Silva HA, Towanabut S, Suwanwela NC, Poungvarin N, Chankrachang S, Wong KS, Eow GB, Navarro JC, Venketasubramanian N, Lee CF, Bousser MG; CHIMES Study Investigators. Chinese medicine neuroaid efficacy on stroke recovery: a double-blind, placebo-controlled, randomized study. Stroke. 2013 Aug;44(8):2093-100. doi: 10.1161/STROKEAHA.113.002055. Epub 2013 Jun 18.
Other Identifiers
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SQSTR03 - CHIMES
Identifier Type: -
Identifier Source: org_study_id
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