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Safety and Feasibility of NRICM301 Added to Usual Care for Adults With Acute Ischemic Stroke
Sponsor: En Chu Kong Hospital
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.
Official title: Evaluating the Clinical Integration of NRICM301, a Food-Grade Innovative Formula, in Acute Ischemic Stroke Care: Safety Observation and Feasibility Assessment
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2026-09
Completion Date
2027-12-31
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
NRICM301
A food-grade formula containing Chi Shao, Chuan Xiong, Hong Qi, and eel, supplied in opaque 50-mL foil sachets. The dose is 100 mL (two sachets) twice daily, for a total of 200 mL daily, for 14 consecutive days. Administration is oral or through a nasogastric feeding tube. The first dose is given within 24 hours after hospital arrival. Ingredient proportions are proprietary. The product is supplied by the National Research Institute of Chinese Medicine, Ministry of Health and Welfare.
Placebo
A placebo drink resembling NRICM301 in appearance, color, and smell, supplied in the same packaging. The dose is 100 mL (two 50-mL sachets) twice daily for 14 consecutive days, orally or through a nasogastric feeding tube. The first dose is given within 24 hours after hospital arrival. The placebo is supplied by the National Research Institute of Chinese Medicine, Ministry of Health and Welfare.
Locations (1)
En Chu Kong Hospital
New Taipei City, Taiwan