CHInese Medicine NeuroAid Efficacy on Stroke Recovery "CHIMES"

Completed

Phase 3 Results N/A

Update History

30 May '12
A location was updated in Hong Kong.
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The overall status was removed for Prince of Wales Hospital.
A location was updated in Georgetown.
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The overall status was removed for Penang General Hospital.
A location was updated in Cebu City.
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The overall status was removed for Visayas Community Medical Center.
A location was updated in Baguio City.
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The overall status was removed for Baguio General Hospital and Medical Center.
A location was updated in Cebu.
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The overall status was removed for Chong Hua Hospital.
A location was updated in Davao.
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The overall status was removed for Davao Medical Center.
A location was updated in Davao.
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The overall status was removed for Brokenshire Hospital.
A location was updated in Davao.
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The overall status was removed for Davao Medical School Foundation.
A location was updated in Iloilo City.
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The overall status was removed for West Visayas State University Hospital.
A location was updated in Manila.
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The overall status was removed for Jose Reyes Memorial Medical Center.
A location was updated in Manila.
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The overall status was removed for Philippine General Hospital.
A location was updated in Manilla.
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The overall status was removed for University of Santo Tomas.
A location was updated in Singapore.
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The overall status was removed for Changi General Hospital.
A location was updated in Singapore.
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The overall status was removed for Singapore General Hospital.
A location was updated in Singapore.
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The overall status was removed for National University Hospital.
A location was updated in Singapore.
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The overall status was removed for National Neuroscience Institute - Tan Tock Seng Campus.
A location was updated in Ragama.
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The overall status was removed for University of Kelaniya.
A location was updated in Muang City.
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The overall status was removed for Chiangmai University Hospital.
A location was updated in Bangkok.
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The overall status was removed for Siriraj hospital.
A location was updated in Bangkok.
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The overall status was removed for Thammasart Hospital.
A location was updated in Bangkok.
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The overall status was removed for King Mongkutla Hospital.
A location was updated in Bangkok.
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The overall status was removed for Prasat neurological institute.
A location was updated in Bangkok.
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The overall status was removed for Rajvithee Hospital.
A location was updated in Bangkok.
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The overall status was removed for King Chulalongkorn Memorial Hospital.
8 Mar '12
A location was updated in Muang City.
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The overall status was removed for Chiangmai University Hospital.
A location was updated in Bangkok.
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The overall status was removed for Rajvithee Hospital.
2 Dec '11
The description was updated.
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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}.
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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.
A location was updated in Cebu City.
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The overall status was removed for Visayas Community Medical Center.
A location was updated in Cebu.
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The overall status was removed for Chong Hua Hospital.
A location was updated in Davao.
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The overall status was removed for Brokenshire Hospital.
A location was updated in Davao.
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The overall status was removed for Davao Medical School Foundation.
6 Oct '11
The eligibility criteria were updated.
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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
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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 ?mol/L, if known), cirrhosis, severe dementia or psychosis - Subject has participated in another clinical trial within the last three months