Clinical trial to evaluate the effectiveness and safety of Nao Xin Qing (NXQ), a standardised herbal medicine in patients with ischaemic Stroke.
- Conditions
- Ischaemic strokeStroke - Ischaemic
- Registration Number
- ACTRN12621000100897
- Lead Sponsor
- Western Sydney University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 88
To participate in this study, participants must:
•Be between the ages of 40-80 years;
•Be an outpatient diagnosed with atherosclerotic ischaemic stroke;
•Have suffered from a stroke no less than 2 weeks and no more than 3 months at screening;
•Have an NIHSS score equal or greater than 5 scores and equal or less than 25 scores;
•Have a premorbid Modified Rankin Scale (mRS) score between 0 and 2;
•Agree to take part in the study as evidenced by a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if the subject is unable to provide consent), has been informed of all pertinent aspects of the study;
•Ability to read and communicate in the English language.
Participants will be excluded from this study if they have any of the following:
•Cerebral haemorrhagic stroke.
•Clinical assessment concluding the cause of ischaemic stroke from brain tumour, trauma, metabolic disorders, rheumatic valvular heart disease, and infectious cause of stroke.
•Participant has non-valvular atrial fibrillation.
•Concomitant clinical conditions affecting neural and motor function assessment including pre-existing dementia, inflammatory or non-inflammatory arthropathies or other medical disorders that result in a premorbid mRS of 3 or greater.
•Abnormal pathology test results: Cr > 1.5 times upper limit of normal (ULN); ALT, AST or ALP > 2 times ULN; PT > 3 second more than ULN; APTT > 10 seconds more than ULN; Plt < 100,000/mcL;
•Patients with severe depression or other psychiatric disorders that have not been stabilised for > 3 months prior to randomisation.
•Known allergy to the medication ingredients.
•Participant of another clinical trial within the past 3 months.
•Consuming D. Kaki L extract.
•Participant requires combination of dual antiplatelet therapy, for example, aspirin and clopidogrel with the exception of aspirin and dipyridample.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IHSS<br>The National Institutes of Health Stroke Scale (NIHSS) is a graded neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments, and ataxia, which has become a standard part of the clinical assessments used in many recent interventional trials. [ Baseline/pre-intervention (Wk0), midpoint (Wk6), primary timepoint (Wk12), follow-up (Wk18).];mRS<br>The modified Rankin scale (mRS) commonly used scale, which measures the degree of disability or dependence in the daily activities of individuals who have suffered a stroke or other neurological disability. <br><br>The mRS is being used to measure the degree of dependence on others.[ Baseline/pre-intervention (Wk0), midpoint (Wk6), primary timepoint (Wk12), follow-up (Wk18).]
- Secondary Outcome Measures
Name Time Method