Stroke Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The participant, or their legal guardian, must be able to understand the study's purpose and risks, and agree to take part by signing a consent form.
• People aged 18 to 80 years old (inclusive) at the time of consent, of any gender.
• People who are able to use effective contraception throughout the study and for at least 6 months after the last dose of the study treatment, and who agree not to donate sperm or eggs during that same period.
• People who have been diagnosed with an acute ischemic stroke (a stroke caused by a blocked blood vessel) where symptoms began no more than 48 hours before enrolment, with a stroke severity score (NIHSS) between 4 and 20, and where brain imaging (CT or MRI) has confirmed there is no bleeding in the brain.
• People who meet Traditional Chinese Medicine (TCM) diagnostic criteria for stroke, which requires at least 2 main symptoms — such as weakness on one side of the body, altered consciousness, speech difficulties, numbness, or facial drooping — or 1 main symptom plus at least 2 additional symptoms such as headache, dizziness, difficulty swallowing, or loss of balance.

Who may not be able to join:

• People whose stroke involves bleeding in the brain, or a mix of bleeding and blockage.
• People with serious heart, liver, or kidney problems, or who have been diagnosed with cancer.
• People who had a previous stroke that left them with significant ongoing disability (a modified Rankin Scale score above 3).
• People who have taken certain medications — such as antibiotics or immune-suppressing drugs — that the trial doctor believes could significantly affect gut bacteria or immune function, within a specific time window around the start of treatment (confirm with trial site for exact timing).
• People who have a known allergy to the study treatment or any of its ingredients.
• People who have previously taken part in this same study.
• People who have donated blood (one unit or more) in the past 90 days, plasma in the past week, or platelets in the past 6 weeks before the screening visit.
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study or within 30 days after finishing treatment.
• People who are currently taking part in, or have taken part in, another clinical trial within the past 90 days.
• People who have had clinically significant thoughts or behaviour related to suicide in the past 12 months, as assessed using a recognised rating scale.
• People who are unable or unwilling to follow the requirements of the study.
• People with significant hearing or vision problems, language barriers, claustrophobia, or other conditions that would interfere with brain assessments or MRI scans.
• People whom the trial doctor determines are unsuitable for any other reason (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.