Clinical trial NCT00554723: CHInese Medicine NeuroAid Efficacy on Stroke Recovery
Official title: A Double Blind, Placebo Controlled, Randomized, Multicenter Study to Investigate CHInese Medicine NeuroAid Efficacy on Stroke Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Infarction
Stroke
Keywords: Stroke
Cerebral infarct
Recovery
Double blind
Randomized
Placebo
Traditional Chinese Medicine
Neuroaid
Lead sponsor: CHIMES Society
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
First posted: 2007-11-07
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Distribution modified Rankin Scale grades for all randomized subjects
timeFrame: 3 months
Secondary outcomes:
measure: NIHSS, Barthel Index, MMSE
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Georgetown
country: Malaysia
facility: Penang General Hospital
state: Penang
city: Cebu City
country: Philippines
facility: Visayas Community Medical Center
state: Cebu
city: Baguio City
country: Philippines
facility: Baguio General Hospital and Medical Center
city: Cebu
country: Philippines
facility: Chong Hua Hospital
city: Davao
country: Philippines
facility: Davao Medical Center
city: Davao
country: Philippines
facility: Brokenshire Hospital
city: Davao
country: Philippines
facility: Davao Medical School Foundation
city: Iloilo City
country: Philippines
facility: West Visayas State University Hospital
city: Manila
country: Philippines
facility: Jose Reyes Memorial Medical Center
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Manilla
country: Philippines
facility: University of Santo Tomas
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Neuroscience Institute - Tan Tock Seng Campus
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Ragama
country: Sri Lanka
facility: University of Kelaniya
city: Muang City
country: Thailand
facility: Chiangmai University Hospital
state: Chiangmai
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Prasat Neurological Institute
city: Bangkok
country: Thailand
facility: Rajvithee Hospital
city: Bangkok
country: Thailand
facility: Thammasart Hospital
city: Bangkok
country: Thailand
facility: King Mongkutla Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: APHP Paris
name: Marie Germaine Bousser, MD
role: STUDY_DIRECTOR
affiliation: National University of Singapore
name: Christopher Chen, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.