CHIMES: CHInese Medicine NeuroAid Efficacy on Stroke Recovery

Sponsor

CHIMES Society (Other)

Overall Status

Completed

CT.gov ID

NCT00554723

Collaborator

National Medical Research Council (NMRC), Singapore (Other)

1,100

Enrollment

Locations

Arms

Duration (Months)

45.8

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Infarction Stroke	Drug: NeuroAid Drug: NeuroAid matched Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

1100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Distribution modified Rankin Scale grades for all randomized subjects [3 months]

Secondary Outcome Measures

NIHSS, Barthel Index, MMSE [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital	Hong Kong		Hong Kong
2	Penang General Hospital	Georgetown	Penang	Malaysia	10990
3	Visayas Community Medical Center	Cebu City	Cebu	Philippines	6000
4	Baguio General Hospital and Medical Center	Baguio City		Philippines	2600
5	Chong Hua Hospital	Cebu		Philippines
6	Davao Medical Center	Davao		Philippines	8000
7	Brokenshire Hospital	Davao		Philippines
8	Davao Medical School Foundation	Davao		Philippines
9	West Visayas State University Hospital	Iloilo City		Philippines	5000
10	Jose Reyes Memorial Medical Center	Manila		Philippines	1003
11	Philippine General Hospital	Manila		Philippines
12	University of Santo Tomas	Manilla		Philippines	1008
13	National University Hospital	Singapore		Singapore	119074
14	National Neuroscience Institute - Tan Tock Seng Campus	Singapore		Singapore	308433
15	Singapore General Hospital	Singapore		Singapore	308433
16	Changi General Hospital	Singapore		Singapore	529889
17	University of Kelaniya	Ragama		Sri Lanka
18	Chiangmai University Hospital	Muang City	Chiangmai	Thailand	50200
19	King Chulalongkorn Memorial Hospital	Bangkok		Thailand	10330
20	Prasat Neurological Institute	Bangkok		Thailand	10400
21	Rajvithee Hospital	Bangkok		Thailand	10400
22	Thammasart Hospital	Bangkok		Thailand	12121
23	King Mongkutla Hospital	Bangkok		Thailand
24	Siriraj Hospital	Bangkok		Thailand