A Randomised, Double-Blind, Placebo Controlled Trial to Evaluate the Effectiveness and Safety of Nao Xin Qing (NXQ), a Standardised Herbal Medicine in Patients with Ischaemic Stroke.

Western Sydney University0 个研究点目标入组 88 人开始时间: 2021年2月1日最近更新: 2023年9月26日

适应症

试验速览

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•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.

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