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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT05066620
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years;
2. Diagnosis of spontaneous ICH, confirmed by brain imaging;
3. Presentation within 48 hours of symptom onset (or last seen well);
4. Meet any of the following criteria: a) NIHSS ≥8, or b) GCS 7-14;
5. Provide written informed consent by patient (or approved surrogate);
Exclusion Criteria:
1. ICH secondary to a structural abnormality in the brain (e.g. cerebrovascular malformation, arterial aneurysm, tumour, Moyamoya disease, trauma, or previous ischaemic stroke), or secondary to presumed cerebrovascular amyloidosis, or secondary to reperfusion treatment for ischaemic stroke, or secondary to anticoagulant treatment, or secondary to antiplatelet treatment.
2. Unlikely to potentially benefit from therapy (e.g. advanced dementia) or judged by responsible treating clinician to have a high likelihood of early death irrespective of treatment;
3. Other medical illness that will interfere with outcome assessments and follow-up (e.g. known significant pre-stroke disability \[modified Rankin scale {mRS} scores 4-5\], advanced cancer and renal failure);
4. Known definite contraindication to the Chinese herbal medicine;
5. Women who are known to be pregnant or lactating;
6. Currently participating in another trial which would interfere with outcome assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05066620
Study Brief:
Protocol Section:
NCT05066620