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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT07163702
Eligibility Criteria:
Inclusion Criteria:
1. Inpatients diagnosed with acute ischemic stroke.
2. Meet the criteria of TCM phlegm-heat and fu-organ excess syndrome.
3. Acute ischemic stroke within 7 days after onset.
4. 6 ≤ NIHSS \<20.
5. Aged 18-70 years, male or female.
6. The patient or representative has signed informed consent.
Exclusion Criteria:
1. Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.
2. NIHSS Ⅰa ≥2.
3. Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )
4. Received or planned thrombolysis or endovascular therapy after onset.
5. Known severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase \> 2.5 times the upper limit of normal value, serum creatinine \> 1.5 times the upper limit of normal value)
6. With cancers or uncontrolled diabetes.
7. The expected survival time is less than 3 months.
8. Patients who have used other traditional Chinese medicine for treating acute ischemic stroke since stroke onset.
9. Patients with severe mental disorders, dementia, or other comorbid diseases that may affect neurological function examination.
10. With a history of alcohol or drug abuse or drug dependence.
11. Those known to be allergic to the investigated drug or its components.
12. Pregnancy, potential pregnancy, or breastfeeding.
13. Currently participating in other clinical trials during the past 3 months.
14. Those who are judged by researchers to have poor compliance or are not suitable for participating in this study for any other reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07163702
Study Brief:
Protocol Section:
NCT07163702