Stroke (CVA) or TIA Clinical Trial
Official title:
Efficacy and Safety of Chinese Medicine Angong Niuhuang Wan for the Treatment of the Stroke: A Randomized, Double-blind,Placebo Controlled Clinical Trial
To evaluate the efficacy and safety of using Chinese Medicine Angong Niuhuang Wan in stroke patients, the modified Rankin Scale (mRS) score will be used as primary outcome, the National Institutes of Health Stroke Scale (NIHSS) score, The Modified Barthel Index (MBI) score and the Montreal Cognitive Assessment (MoCA) scores will be used as secondary outcome measures.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Chinese adults aged 40 or above; 2. diagnosed as a stroke by a neurologist, with imaging of CT or MRI support; 3. Neurologist confirms the symptoms of stroke occur within 28 days and are clinically stable. In the past 48 hours, the condition of the nervous system has not deteriorated significantly; 4. TCM diagnosis is a stroke and belongs to a heat syndrome; 5. There is a movement defect caused by stroke; 6. The severity of stroke was scored 5-25 by the National Institutes of Health Brain Stroke Scale (NIHSS); 7. Informed consent will be given by participant or its representatives Exclusion Criteria: 1. The movement defects are not associated with stroke. Before commencement of study treatment, patient has physical activity dysfunction caused by lameness , osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. that may affect neurological function examination; 2. Subjects are unlikely to come back for follow-up visits during the 24-week study period; 3. The subject has a brain tumor on a computed tomography scan (CT); 4. The subject has thrombocytopenia (known platelet count <100,000 / mm3) or coagulopathy disease; 5. Taking warfarin or other anticoagulant; 6. Concomitant diseases such as severe hypertension or diabetes; 7. Comorbidities or complications associated with drug evaluation; 8. Pregnant or breast-feeding female. 9. The alanine aminotransferase (ALT) value is 1.5 times higher than the normal maximum value in liver function test and the estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 in the renal function test. 10. Present the sign of pure yin syndrome or yin / yang defecation in TCM diagnosis; 11. Subject has G6PD 12. Known swallowing problem 13. Dependent in all daily life activities |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score of neurological deficit and adverse events | compare the therapeutic effects, the score of neurological deficit and adverse events between the two groups by using questionnaire of mRS, higher scores mean a worse outcome | 24 weeks | |
Secondary | Mortality and recurrence rates of stroke | Compare the mortality and recurrence rates of stroke between two groups also the abilities of daily ability using questionnaires of NIHSS (higher scores mean a worse outcome), mBI and MOCA-HK (higher scores mean a better outcome) | 24 weeks |
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