CHInese Medicine NeuroAid Efficacy on Stroke Recovery

Stroke Clinical Trial

— CHIMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554723
• Other study ID #: SQSTR03 - CHIMES
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2007
• Last updated: April 30, 2014
• Start date: May 2007
• Est. completion date: August 2012

Study information

• Verified date: April 2014
• Source: CHIMES Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthoritySingapore: Domain Specific Review BoardsPhilippines: Bureau of Food and DrugsHong Kong: Joint CUHK-NTEC Clinical Research Ethics CommitteeHong Kong: Department of HealthThailand: Food and Drug AdministrationThailand: Ministry of Public HealthMalaysian: Malaysian Research Ethics Committee
• Study type: Interventional

Clinical 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.

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}.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Stroke

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong
Malaysia	Penang General Hospital	Georgetown	Penang
Philippines	Baguio General Hospital and Medical Center	Baguio City
Philippines	Chong Hua Hospital	Cebu
Philippines	Visayas Community Medical Center	Cebu City	Cebu
Philippines	Brokenshire Hospital	Davao
Philippines	Davao Medical Center	Davao
Philippines	Davao Medical School Foundation	Davao
Philippines	West Visayas State University Hospital	Iloilo City
Philippines	Jose Reyes Memorial Medical Center	Manila
Philippines	Philippine General Hospital	Manila
Philippines	University of Santo Tomas	Manilla
Singapore	Changi General Hospital	Singapore
Singapore	National Neuroscience Institute - Tan Tock Seng Campus	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Sri Lanka	University of Kelaniya	Ragama
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	King Mongkutla Hospital	Bangkok
Thailand	Prasat Neurological Institute	Bangkok
Thailand	Rajvithee Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Thammasart Hospital	Bangkok
Thailand	Chiangmai University Hospital	Muang City	Chiangmai

Sponsors (2)

Lead Sponsor	Collaborator
CHIMES Society	National Medical Research Council (NMRC), Singapore

Countries where clinical trial is conducted

Hong Kong,  Malaysia,  Philippines,  Singapore,  Sri Lanka,  Thailand, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution modified Rankin Scale grades for all randomized subjects		3 months	No
Secondary	NIHSS, Barthel Index, MMSE		3 months	Yes