NCT00554723

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2007

Longer than P75 for phase_3

Geographic Reach
6 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

5.3 years

First QC Date

November 5, 2007

Last Update Submit

April 30, 2014

Conditions

Cerebral InfarctionStroke

Keywords

StrokeCerebral infarctRecoveryDouble blindRandomizedPlaceboTraditional Chinese MedicineNeuroaid

Outcome Measures

Primary Outcomes (1)

  • Distribution modified Rankin Scale grades for all randomized subjects

    3 months

Secondary Outcomes (1)

  • NIHSS, Barthel Index, MMSE

    3 months

Study Arms (2)

A

EXPERIMENTAL

NeuroAid

Drug: NeuroAid

B

PLACEBO COMPARATOR

NeuroAid matched Placebo

Drug: NeuroAid matched Placebo

Interventions

NeuroAidDRUG

4 capsules 3 times daily, for three months

Also known as: Danqi Piantan Jiaonang (In China)
A
NeuroAid matched PlaceboDRUG

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Penang General Hospital

George Town, Pulau Pinang, 10990, Malaysia

Location

Visayas Community Medical Center

Cebu City, Cebu, 6000, Philippines

Location

Baguio General Hospital and Medical Center

Baguio City, 2600, Philippines

Location

Chong Hua Hospital

Cebu, Philippines

Location

Davao Medical Center

Davao City, 8000, Philippines

Location

Brokenshire Hospital

Davao City, Philippines

Location

Davao Medical School Foundation

Davao City, Philippines

Location

West Visayas State University Hospital

Iloilo City, 5000, Philippines

Location

Jose Reyes Memorial Medical Center

Manila, 1003, Philippines

Location

University of Santo Tomas

Manila, 1008, Philippines

Location

Philippine General Hospital

Manila, Philippines

Location

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

National Neuroscience Institute - Tan Tock Seng Campus

Singapore, Singapore, 308433, Singapore

Location

Singapore General Hospital

Singapore, Singapore, 308433, Singapore

Location

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

University of Kelaniya

Ragama, Sri Lanka

Location

Chiangmai University Hospital

Muang City, Chiangmai, 50200, Thailand

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Prasat Neurological Institute

Bangkok, 10400, Thailand

Location

Rajvithee Hospital

Bangkok, 10400, Thailand

Location

Thammasart Hospital

Bangkok, 12121, Thailand

Location

King Mongkutla Hospital

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

Related Publications (8)

  • 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.

    PMID: 20395679BACKGROUND

  • 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.

    PMID: 19164787BACKGROUND

  • 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.

    PMID: 18417963BACKGROUND

  • 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.

    PMID: 19236501BACKGROUND

  • 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.

    PMID: 39334395DERIVED

  • 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.

    PMID: 26628386DERIVED

  • 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.

    PMID: 24135924DERIVED

  • 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.

    PMID: 23780952DERIVED

MeSH Terms

Conditions

Cerebral InfarctionStroke

Interventions

Neuroaid

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Marie Germaine Bousser, MD

    APHP Paris

    STUDY DIRECTOR

  • Christopher Chen, MBBS

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 7, 2007

Study Start

May 1, 2007

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 1, 2014

Record last verified: 2014-04

Locations

SG(4)MY(1)TH(7)HK(1)PH(10)SR(1)