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Evaluating the Clinical Integration of NRICM301, a Food-Grade Innovative Formula, in Acute Ischemic Stroke Care: Safety Observation and Feasibility Assessment

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
En Chu Kong Hospital
RECRUITING
New Taipei City
Contact Information
Primary
Chin-Hsien Chang
01399@km.eck.org.tw
+886-2-672-3456
Time Frame
Start Date: 2026-09
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 45
Treatments
Experimental: NRICM301 Plus Standard Care
Participants will receive NRICM301, 100 mL per dose (two 50-mL sachets), twice daily in the morning and evening for 14 consecutive days, orally or through a nasogastric feeding tube. The first dose will be administered within 24 hours after hospital arrival. Standard acute ischemic stroke care will continue throughout participation.
Placebo_comparator: Placebo Plus Standard Care
Participants will receive a placebo drink resembling NRICM301 in appearance, color, and smell, 100 mL per dose (two 50-mL sachets), twice daily in the morning and evening for 14 consecutive days, orally or through a nasogastric feeding tube. The first dose will be administered within 24 hours after hospital arrival. Standard acute ischemic stroke care will continue throughout participation.
Related Therapeutic Areas
Sponsors
Leads: En Chu Kong Hospital
Collaborators: National Research Institute of Chinese Medicine, Ministry of Health and Welfare

This content was sourced from clinicaltrials.gov

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