Last updated: January 28, 2021
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting
Phase
2/3
Condition
Cerebral Ischemia
Stroke
Treatment
N/AClinical Study ID
NCT04236427
ANP study
Ages 40-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Chinese adults aged 40 or above;
- diagnosed as a stroke by a neurologist, with imaging of CT or MRI support;
- Neurologist confirms the symptoms of stroke occur within 28 days and are clinicallystable. In the past 48 hours, the condition of the nervous system has not deterioratedsignificantly;
- TCM diagnosis is a stroke and belongs to a heat syndrome;
- There is a movement defect caused by stroke;
- The severity of stroke was scored 5-25 by the National Institutes of Health BrainStroke Scale (NIHSS);
- Informed consent will be given by participant or its representatives
Exclusion
Exclusion Criteria:
- The movement defects are not associated with stroke. Before commencement of studytreatment, patient has physical activity dysfunction caused by lameness ,osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. that may affectneurological function examination;
- Subjects are unlikely to come back for follow-up visits during the 24-week studyperiod;
- The subject has a brain tumor on a computed tomography scan (CT);
- The subject has thrombocytopenia (known platelet count <100,000 / mm3) or coagulopathydisease;
- Taking warfarin or other anticoagulant;
- Concomitant diseases such as severe hypertension or diabetes;
- Comorbidities or complications associated with drug evaluation;
- Pregnant or breast-feeding female.
- The alanine aminotransferase (ALT) value is 1.5 times higher than the normal maximumvalue in liver function test and the estimated glomerular filtration rate (eGFR) <30ml/min/1.73 m2 in the renal function test.
- Present the sign of pure yin syndrome or yin / yang defecation in TCM diagnosis;
- Subject has G6PD
- Known swallowing problem
- Dependent in all daily life activities
Study Design
Total Participants: 100
Study Start date:
October 15, 2019
Estimated Completion Date:
June 30, 2023
Study Description
Connect with a study center
The Chinese University of Hong Kong
Hong Kong,
Hong KongActive - Recruiting
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