Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT04236427
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT04236427
Study Brief:
Protocol Section:
NCT04236427