CHInese Medicine NeuroAid Efficacy on Stroke Recovery (CHIMES)

April 30, 2014 updated by: CHIMES Society

A Double Blind, Placebo Controlled, Randomized, Multicenter Study to Investigate CHInese Medicine NeuroAid Efficacy on Stroke Recovery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
  • Malaysia
    • Penang
      • Georgetown, Penang, Malaysia, 10990
        • Penang General Hospital
  • Philippines
      • Baguio City, Philippines, 2600
        • Baguio General Hospital and Medical Center
      • Cebu, Philippines
        • Chong Hua Hospital
      • Davao, Philippines, 8000
        • Davao Medical Center
      • Davao, Philippines
        • Brokenshire Hospital
      • Davao, Philippines
        • Davao Medical School Foundation
      • Iloilo City, Philippines, 5000
        • West Visayas State University Hospital
      • Manila, Philippines
        • Philippine General Hospital
      • Manila, Philippines, 1003
        • Jose Reyes Memorial Medical Center
      • Manilla, Philippines, 1008
        • University of Santo Tomas
    • Cebu
      • Cebu City, Cebu, Philippines, 6000
        • Visayas Community Medical Center
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 529889
        • Changi General Hospital
      • Singapore, Singapore, 308433
        • National Neuroscience Institute - Tan Tock Seng Campus
      • Singapore, Singapore, 308433
        • Singapore General Hospital
  • Sri Lanka
      • Ragama, Sri Lanka
        • University of Kelaniya
  • Thailand
      • Bangkok, Thailand
        • Siriraj Hospital
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10400
        • Prasat Neurological Institute
      • Bangkok, Thailand, 10400
        • Rajvithee Hospital
      • Bangkok, Thailand, 12121
        • Thammasart Hospital
      • Bangkok, Thailand
        • King Mongkutla Hospital
    • Chiangmai
      • Muang City, Chiangmai, Thailand, 50200
        • Chiangmai University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
NeuroAid
Drug: NeuroAid
4 capsules 3 times daily, for three months
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distribution modified Rankin Scale grades for all randomized subjects
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
NIHSS, Barthel Index, MMSE
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHIMES Society

Collaborators

National Medical Research Council (NMRC), Singapore

Investigators

  • Study Director: Marie Germaine Bousser, MD, APHP PARIS
  • Principal Investigator: Christopher Chen, MBBS, National University, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 7, 2007

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

April 30, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQSTR03 - CHIMES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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