None listed
Conditions
Brief summary
Stroke is the third leading cause of death in Australia. Ischaemic stroke accounts for ~80% of all stroke cases and is caused by a narrowing or obstruction of the blood vessels resulting in oxygen and nutrient deprivation. Conventional post-stroke management involves combining pharmacotherapy and rehabilitative therapies. Nao Xin Qing (NXQ) is a TGA-approved product (AUSTL196297) in Australia. NXQ is a novel herbal formula made from the standardised extract of persimmon leaves. NXQ has been used clinically in China for numerous years in the treatment of apoplexy, coronary heart disease and enhance recovery from ischemic stroke. The aim of this randomised double-blind controlled study is to assess the clinical effectiveness of NXQ for ischaemic stroke patients during rehabilitation phase. This will provide preliminary data whether NXQ can be used as an effective treatment of ischaemic stroke recovery, to prevent recurrence of stroke and improve quality of life of stroke survivors.
Interventions
This study will be conducted as a two-arm randomized, double-blind, placebo controlled clinical trial of 36 weeks, including a 12-week intervention and 26-week follow-up.
For a two-arm trial, participants will be randomized after informed consent is obtained, into two parallel treatment groups:
a. Intervention group taking NXQ (Active)
b. Placebo control group (Placebo)
Intervention
Active NXQ 0.41g tablet, composition:
• Diospyros Kaki leaf extract 50 mg (active component)
• Starch
• Sucrose
This study will be conducted as a two-arm randomized, double-blind, placebo controlled clinical trial of 36 weeks, including a 12-week intervention and 26-week follow-up. For a two-arm trial, participants will be randomized after informed consent is obtained, into two parallel treatment groups: a. Intervention group taking NXQ (Active) b. Placebo control group (Placebo) Intervention Active NXQ 0.41g tablet, composition: • Diospyros Kaki leaf extract 50 mg (active component) • Starch • Sucrose Powder • Magnesium stearate • Microcrystalline cellulose Participants in Group 1 will take 3 NXQ tablets, three times per day for 12 weeks. At each appointment, an allocation of medication will be dispensed to participants by research personnel according to the pre-coded container labelling. Participants will be required to return the original containers and any unused medication for monitoring and adherence to the intervention. Any unused medication will then be destroyed locally with approval of the coordinating chief investigator. All delivered and dispensed, unused and returned quantities will be recorded in a medication log.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed