NCT07900503 Safety and Feasibility of NRICM301 Added to Usual Care for Adults With Acute Ischemic Stroke

Eligibility & Interventions

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This trial targets 45 participants in total. It began in 2026-09 with a primary completion date of 2027-09.

Brief Summary

Acute ischemic stroke occurs when blood flow to part of the brain is blocked. This study will assess the safety and feasibility of adding NRICM301, a food-grade formula also called Taiwan Xingnao No. 1, to usual care for adults with acute ischemic stroke. The study plans to enroll 45 participants at En Chu Kong Hospital in Taiwan. Participants will be assigned by chance in a 1:1 ratio to receive NRICM301 or a similar-looking placebo drink for 14 days, in addition to usual stroke care. Each dose is 100 mL, taken twice daily by mouth or through a nasogastric feeding tube. The first dose will be given within 24 hours after arrival at the hospital. Participants and study personnel who assess outcomes will not know which drink participants receive. The main question is whether the proportion of participants experiencing adverse events differs between the two groups from the first dose through the 90-day follow-up visit. Blood tests, stroke severity, disability, ability to perform daily activities, hospital and intensive care use, and inflammatory markers will also be evaluated. This exploratory study is intended to identify safety signals and estimate changes that can help plan a larger study; it is not designed to establish definitive treatment effectiveness.

Eligibility Criteria

Inclusion Criteria: * Male or female adults aged 20 years or older at screening. * Acute ischemic stroke diagnosed by a clinician based on clinical assessment and imaging findings, with a baseline National Institutes of Health Stroke Scale (NIHSS) score of 5 to 22. Exclusion Criteria: * Receipt of, or planned treatment with, mechanical thrombectomy or intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA); or use within 7 days before screening or current use of other Chinese herbal medicines, including single-herb or compound preparations, herbal injections, and concentrated herbal preparations; supplements primarily containing herbs that may affect coagulation or platelet function, such as Dan Shen, ginkgo leaf, Dang Gui, turmeric, or St. John's wort; or specified dietary supplements, including fish oil/omega-3 at more than 2 g/day, vitamin E at more than 400 IU/day, or garlic extract. * Another stroke within the 7 days preceding the current stroke onset, postoperative stroke, stroke due to a rare cause, or a pre-stroke modified Rankin Scale score of 4 or higher. * Imaging evidence of intracranial hemorrhage or another non-ischemic intracranial lesion; a cerebral arteriovenous malformation with high bleeding risk; a history of abnormal bleeding or a bleeding disorder; or abnormal coagulation function. * Severe hepatic or renal impairment as determined by a physician. * Current pregnancy or breastfeeding. * Inability to accept an intervention containing animal-derived ingredients. * Known allergy to Chi Shao, Chuan Xiong, Hong Qi, or fish ingredients in NRICM301. * Participation within 3 months before screening in another interventional clinical trial involving a drug, biological product, herbal medicine, or nutritional supplement with systemic physiological effects. Participation in a noninvasive medical device study, such as a blood pressure monitor or wearable monitoring device study, may be permitted after principal investigator assessment. Participation in a purely behavioral intervention, health education, psychological assessment, or cognitive training study may also be permitted if it does not affect this study's outcomes or increase participant risk. * Unwillingness or inability to comply with study procedures. * Unwillingness or inability of the participant or a legally authorized representative to provide written informed consent. * Any other condition that may affect safety, clinical assessment, or interpretation of the study results, or that makes participation inappropriate in the investigator's clinical judgment.

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