CHIMES Society aims at measuring the efficacy of NeuroAiD using Western clinical trials methodology. Positive results from such a trial will establish clearly in western medicine the potential of NeuroAiD and support the awareness of such treatment's availability in the medical and patient communities.

The goal of the trial is to test the hypothesis that NeuroAiD is superior to Placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction with intermediate range of severity (6

This is a multi-center double blind controlled randomized trial comparing NeuroAiD versus a matched placebo assessing efficacy after three months of treatment.

The Study Endpoints are:

  • Primary Efficacy Outcomes is the modified Rankin Scale grades at 3 months for all randomized subjects.
  • Secondary Efficacy Outcomes are standard Western scales such as for stroke: NIHSS, mRS, Barthel index, mini-mental State Examination (MMSE).

Eligibility criteria have been chosen to allow most of the ischemic stroke patients to be included in the study and benefit from the TCM treatment.

Patient participation to the study will consist of a simple procedure:

  • Recruitment: The investigator in charge of the trial determines whether the patient fits the criteria of inclusion and exclusion. Once eligibility is confirmed, the patient is offered to participate to the trial and is asked to sign a consent form.
  • Assignment: The patient eligible is randomly assigned either to NeuroAiD or to a matched-placebo for 3 months.
  • Initial assessment: On the first day of treatment, the doctors assess the patient neurological disability on 3 stroke standard scales used in western clinical trial methodology: NIHSS (neurological deficits), mRS (functional outcome) and MMSE (cognitive functions).
  • Assessment at discharge from the hospital: When the patient leaves the hospital, the doctor will conduct a similar examination to assess the patient improvement.
  • Assessment at 1 month: This assessment is performed by phone and assesses only patient autonomy (mRS).
  • Assessment at 3 months: the patient recovery is assessed by investigators on the same three standards scales. Patient independence from any help, physical or verbal will also be measured by a fourth test called Barthel Index.

As per standard clinical trial guidelines, the CHIMES Society has appointed a Data and Safety Monitoring Board that will provide an unbiased process through which the CHIMES study will be monitored and patient safety protected.

Inclusion criteria

A subject will be eligible for inclusion in the trial only if all the following criteria apply at Baseline:

  • Cerebral infarction of moderate severity
  • Beginning of treatment within 48 hours after symptoms onset
  • 18 years old and above
  • No existing disability pre-stroke (mRS<1)
  • Non childbearing potential for females
Exclusion criteria

A subject will not be eligible for inclusion in the trial if any of the following criteria apply at baseline:

  • Evidence of an other diagnosis (hemorrhage...)
  • Patient benefiting from thrombolysis
  • Known contra-indication for the use of all antiplatelet drugs
  • Patient on anticoagulation therapy
  • Co-existing systemic diseases (terminal cancer, renal failure cirrhosis, severe dementia or psychosis)
  • Recent participation in another clinical trial within the last three months
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