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CHInese Medicine NeuroAid Efficacy on Stroke Recovery (CHIMES)

Primary Purpose

Cerebral Infarction, Stroke

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NeuroAid
NeuroAid matched Placebo
Sponsored by
CHIMES Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring Stroke, Cerebral infarct, Recovery, Double blind, Randomized, Placebo, Traditional Chinese Medicine, Neuroaid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital
  • Penang General Hospital
  • Visayas Community Medical Center
  • Baguio General Hospital and Medical Center
  • Chong Hua Hospital
  • Davao Medical Center
  • Brokenshire Hospital
  • Davao Medical School Foundation
  • West Visayas State University Hospital
  • Jose Reyes Memorial Medical Center
  • Philippine General Hospital
  • University of Santo Tomas
  • National University Hospital
  • National Neuroscience Institute - Tan Tock Seng Campus
  • Singapore General Hospital
  • Changi General Hospital
  • University of Kelaniya
  • Chiangmai University Hospital
  • King Chulalongkorn Memorial Hospital
  • Prasat Neurological Institute
  • Rajvithee Hospital
  • Thammasart Hospital
  • King Mongkutla Hospital
  • Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

NeuroAid

NeuroAid matched Placebo

Outcomes

Primary Outcome Measures

Distribution modified Rankin Scale grades for all randomized subjects

Secondary Outcome Measures

NIHSS, Barthel Index, MMSE

Full Information

First Posted
November 5, 2007
Last Updated
April 30, 2014
Sponsor
CHIMES Society
Collaborators
National Medical Research Council (NMRC), Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00554723
Brief Title
CHInese Medicine NeuroAid Efficacy on Stroke Recovery
Acronym
CHIMES
Official Title
A Double Blind, Placebo Controlled, Randomized, Multicenter Study to Investigate CHInese Medicine NeuroAid Efficacy on Stroke Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHIMES Society
Collaborators
National Medical Research Council (NMRC), Singapore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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}.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction, Stroke
Keywords
Stroke, Cerebral infarct, Recovery, Double blind, Randomized, Placebo, Traditional Chinese Medicine, Neuroaid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
NeuroAid
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
NeuroAid matched Placebo
Intervention Type
Drug
Intervention Name(s)
NeuroAid
Other Intervention Name(s)
Danqi Piantan Jiaonang (In China)
Intervention Description
4 capsules 3 times daily, for three months
Intervention Type
Drug
Intervention Name(s)
NeuroAid matched Placebo
Intervention Description
NeuroAid matched Placebo, 4 capsules 3 times daily, for three months
Primary Outcome Measure Information:
Title
Distribution modified Rankin Scale grades for all randomized subjects
Time Frame
3 months
Secondary Outcome Measure Information:
Title
NIHSS, Barthel Index, MMSE
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Germaine Bousser, MD
Organizational Affiliation
APHP Paris
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christopher Chen, MBBS
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Penang General Hospital
City
Georgetown
State/Province
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Visayas Community Medical Center
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Baguio General Hospital and Medical Center
City
Baguio City
ZIP/Postal Code
2600
Country
Philippines
Facility Name
Chong Hua Hospital
City
Cebu
Country
Philippines
Facility Name
Davao Medical Center
City
Davao
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Brokenshire Hospital
City
Davao
Country
Philippines
Facility Name
Davao Medical School Foundation
City
Davao
Country
Philippines
Facility Name
West Visayas State University Hospital
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Jose Reyes Memorial Medical Center
City
Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
Philippine General Hospital
City
Manila
Country
Philippines
Facility Name
University of Santo Tomas
City
Manilla
ZIP/Postal Code
1008
Country
Philippines
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Neuroscience Institute - Tan Tock Seng Campus
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
University of Kelaniya
City
Ragama
Country
Sri Lanka
Facility Name
Chiangmai University Hospital
City
Muang City
State/Province
Chiangmai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Prasat Neurological Institute
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Rajvithee Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Thammasart Hospital
City
Bangkok
ZIP/Postal Code
12121
Country
Thailand
Facility Name
King Mongkutla Hospital
City
Bangkok
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
20395679
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.
Results Reference
background
PubMed Identifier
19164787
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.
Results Reference
background
PubMed Identifier
18417963
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. Erratum In: Cerebrovasc Dis. 2009;27(4):412.
Results Reference
background
PubMed Identifier
19236501
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.
Results Reference
background
PubMed Identifier
26628386
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.
Results Reference
derived
PubMed Identifier
24135924
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.
Results Reference
derived
PubMed Identifier
23780952
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.
Results Reference
derived

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CHInese Medicine NeuroAid Efficacy on Stroke Recovery

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