Chinese Herbal Medicine in Acute INtracerebral Haemorrhage (CHAIN) Trial

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine FYTF-919 in reducing haematoma and bleeding after acute ICH from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study aims to determine the effectiveness and safety of TCM in a larger sample of patients with moderate-severe ICH and provide evidence for TCM clinical guidelines on ICH management. The presumed mechanism of action is in promoting the reabsorption of the haematoma and perihematomal oedema in ICH.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborator: The George Institute

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.