AzTrials
AzTrials

Cerebral InfarctionPhase 3CHIMESNCT00554723

CHInese Medicine NeuroAid Efficacy on Stroke Recovery

A Phase 3 study testing NeuroAid in people with Cerebral Infarction and Stroke, run by CHIMES Society at 24 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebral Infarction, Stroke
What is being tested?
NeuroAid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,100 participants
Where
24 sitesin 6 countries
Study dates
May 2007to Aug 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

24 sites in 6 countries.

24 sites in 6 countries

Philippines10 sites

  • Baguio General Hospital and Medical Center

    Baguio City, 2600

  • Chong Hua Hospital

    Cebu

  • Visayas Community Medical Center

    Cebu City, Cebu, 6000

  • Davao Medical Center

    Davao City, 8000

  • Brokenshire Hospital

    Davao City

  • Davao Medical School Foundation

    Davao City

  • West Visayas State University Hospital

    Iloilo City, 5000

  • Jose Reyes Memorial Medical Center

    Manila, 1003

  • University of Santo Tomas

    Manila, 1008

  • Philippine General Hospital

    Manila

Other trials in Philippines

Thailand7 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Prasat Neurological Institute

    Bangkok, 10400

  • Rajvithee Hospital

    Bangkok, 10400

  • Thammasart Hospital

    Bangkok, 12121

  • King Mongkutla Hospital

    Bangkok

  • Siriraj Hospital

    Bangkok

  • Chiangmai University Hospital

    Muang City, Chiangmai, 50200

Other trials in Thailand

Singapore4 sites

  • National University Hospital

    Singapore, Singapore, 119074

  • National Neuroscience Institute - Tan Tock Seng Campus

    Singapore, Singapore, 308433

  • Singapore General Hospital

    Singapore, Singapore, 308433

  • Changi General Hospital

    Singapore, Singapore, 529889

Other trials in Singapore

Hong Kong1 site

  • Prince of Wales Hospital

    Hong Kong

Other trials in Hong Kong

Malaysia1 site

  • Penang General Hospital

    George Town, Pulau Pinang, 10990

Other trials in Malaysia

Sri Lanka1 site

  • University of Kelaniya

    Ragama

Other trials in Sri Lanka

About this study

Official title: 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.

Read the 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}.

Being tested
NeuroAid, NeuroAid matched Placebo
Keywords
Stroke, Cerebral infarct, Recovery, Double blind, Randomized, Placebo, Traditional Chinese Medicine, Neuroaid
Medical subject headings
Cerebral Infarction, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeuroAidDrug

    Also called Danqi Piantan Jiaonang (In China)

    4 capsules 3 times daily, for three months

  • NeuroAid matched PlaceboDrug

    NeuroAid matched Placebo, 4 capsules 3 times daily, for three months

Study groups in NCT00554723
Study groupRoleWhat they receive
AExperimentalNeuroAid
Receives: Drug: NeuroAid
BPlacebo comparatorNeuroAid matched Placebo
Receives: Drug: NeuroAid matched Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distribution modified Rankin Scale grades for all randomized subjects

    Measured: 3 months

Secondary outcomes (1)

  1. NIHSS, Barthel Index, MMSE

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00554723
Sponsor's protocol ID
SQSTR03 - CHIMES
Acronym
CHIMES
Status last verified
Apr 2014
First submitted
5 Nov 2007
Last updated
1 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20395679

  • 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.

    PubMed 19164787

  • 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.

    PubMed 18417963

  • 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.

    PubMed 19236501

  • 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.

    PubMed 39334395

  • 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.

    PubMed 26628386

  • 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.

    PubMed 24135924

  • 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.

    PubMed 23780952

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NeuroAid in people with Cerebral Infarction and Stroke, run by CHIMES Society at 24 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Philippines, Thailand, Singapore, Hong Kong, Malaysia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution modified Rankin Scale grades for all randomized subjects (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00554723, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in