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

Prior treatment

• 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.

Other illness

• 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.
• Known allergy to Chi Shao, Chuan Xiong, Hong Qi, or fish ingredients in NRICM301.
• 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.

Lab values

• 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.

Other

• Current pregnancy or breastfeeding.
• Inability to accept an intervention containing animal-derived ingredients.
• Unwillingness or inability to comply with study procedures.
• Unwillingness or inability of the participant or a legally authorized representative to provide written informed consent.

• 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.