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NCT07902934

Safety of NRICM301 Added to Standard Care in Adults With Acute Ischemic Stroke

Sponsor: Tri-Service General Hospital (TSGH)

View on ClinicalTrials.gov

Summary

This study will examine the short-term safety and tolerability of NRICM301, a food-grade herbal formula also known as Taiwan Xingnao No. 1, when added to standard care for adults hospitalized with acute ischemic stroke. An ischemic stroke occurs when blood flow to part of the brain is blocked. The study will enroll up to 45 adults at Tri-Service General Hospital in Taiwan. Participants will be randomly assigned to receive either NRICM301 or a matching placebo for 14 days. Both groups will continue to receive standard stroke care. The study drink will be given by mouth or through a nasogastric tube, starting within 24 hours after hospital arrival. Participants and the study personnel involved in treatment and assessments will not know which study product each participant receives. The main question is whether the proportion of participants who experience an adverse event considered at least possibly related to the study product differs between the two groups through Day 15. The study will also assess blood test results, neurological function, ability to perform daily activities, hospital and intensive care use, and inflammation markers. Follow-up is planned through Day 91. This is an exploratory safety study; it is not designed to establish definitive treatment effectiveness.

Official title: Clinical Study on the Application of NRICM301 in Acute Ischemic Stroke: Observing the Safety and Application Status of a Food-Grade Herbal Formula

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09

Completion Date

2027-12-31

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

DIETARY_SUPPLEMENT

NRICM301

NRICM301 is a food-grade formula containing Chi Shao, Chuan Xiong, Hong Qi, and eel. Ingredient proportions are proprietary. It is supplied in opaque 50-mL aluminum sachets. Participants receive two s

OTHER

Matching Placebo

Matching placebo is supplied in opaque 50-mL aluminum sachets with the same packaging and volume as NRICM301 and closely matched appearance, color, and odor. Participants receive two sachets per dose (100 mL), twice daily approximately 12 hours apart, for 14 consecutive days (200 mL per day), orally or via a nasogastric tube. Timing relative to meals and routine Western medicines is the same as for NRICM301. The first dose must be administered within 24 hours after hospital arrival.

Inclusion Criteria: * Male or female participants aged 20 years or older at screening. * Acute ischemic stroke diagnosed by a physician based on clinical assessment and imaging, with a baseline National Institutes of Health Stroke Scale score of 5 to 22. * Willingness to provide blood samples for stroke-related inflammatory cytokine testing. * Ability to understand the study and willingness to provide written informed consent, or completion of the consent process with a person legally authorized to provide consent. Exclusion Criteria: * Receipt of, or planned treatment with, mechanical thrombectomy or intravenous thrombolysis with rt-PA or tenecteplase; or use within 7 days before screening or current use of other herbal medicines, including single-herb or multi-herb preparations, herbal injections or concentrated herbal preparations; supplements primarily containing herbs affecting coagulation or platelet function, such as Salvia miltiorrhiza, ginkgo, dong quai, turmeric or St. John's wort; or specified dietary supplements, including fish oil or omega-3 at more than 2 g/day, vitamin E at more than 400 IU/day, or garlic extracts. * A prior stroke within the 7 days preceding onset of the current stroke, postoperative stroke, stroke due to a rare cause, or a prestroke modified Rankin Scale score of 4 or higher. * Imaging evidence of intracranial hemorrhage or another nonischemic intracranial lesion; a cerebral arteriovenous malformation with a high bleeding risk; active abnormal bleeding or active bleeding; a history of a bleeding disorder or nontraumatic intracranial hemorrhage; or coagulation dysfunction or abnormal coagulation parameters considered clinically significant by a physician. * Severe hepatic or renal impairment considered clinically significant by a physician, or pregnancy or breastfeeding based on participant self-report. * Inability to accept a study product containing animal-derived food ingredients. * Known allergy to Chi Shao, Chuan Xiong, Hong Qi or fish ingredients. * Participation within 3 months before screening in another interventional clinical trial involving a drug, biological product, herbal product or nutritional supplement with systemic physiological effects. Participation in a noninvasive medical device study, such as a blood pressure monitor or wearable monitor, may be permitted after principal investigator assessment. Purely behavioral, educational counseling, psychological assessment or cognitive training studies may also be permitted after principal investigator assessment if their interventions do not affect this study's outcomes or increase participation risk. * Unwillingness or inability to comply with study procedures. * Unwillingness or inability of the participant or the legally authorized person to provide written informed consent. * Any other condition that may affect participant safety, assessment of clinical measures or interpretation of study results, or that makes participation inappropriate in the physician's professional judgment.