An interventional study of NRICM301 and Placebo in Acute Ischemic Stroke, sponsored by En Chu Kong Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by En Chu Kong Hospital · Not applicable, Interventional, and Supportive care
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.
This single-center exploratory feasibility trial evaluates the integration of NRICM301 into standard care for acute ischemic stroke. An independent staff member who does not participate in recruitment, administration, or assessment will generate a randomized allocation sequence using randomly mixed block sizes of four and six. Allocation will be concealed, and study products will have identical packaging labeled with participant numbers. Individual allocation envelopes will be held separately for emergency unblinding when knowledge of treatment assignment is essential for urgent medical management.
Recruitment will take place through the emergency department after necessary acute medical care has been provided and vital signs are stable. The consent process will be conducted by study personnel separate from the physician providing frontline emergency care. Participants or their legally authorized representatives will receive at least 20 minutes to consider participation. Participants who regain decision-making capacity after representative consent will be asked to provide their own written consent.
All participants will continue standard stroke care. Product use will be recorded during hospitalization and after discharge. Telephone reminders, dosing records, and returned unused product will support adherence assessment. If an in-person 90-day visit is not possible, functional assessments may be conducted by telephone, with the assessment method documented.
The safety analysis set includes randomized participants who receive at least one dose. The modified intention-to-treat set includes randomized participants who receive at least one dose and have at least one post-baseline neurological, functional, or inflammatory-marker assessment. The per-protocol set requires completion of the 14-day intervention, at least 80% overall adherence, the final follow-up assessment, and no major protocol deviation. Analyses will emphasize descriptive statistics, effect estimates, and 95% confidence intervals. Secondary comparisons are exploratory, and no adjustment for multiple comparisons is planned. Missing values will not be imputed; the longitudinal NIHSS analysis will use available observations.
An internal safety group led by the principal investigator and co-investigators will review safety data at least quarterly. No independent data monitoring committee is planned. Prespecified individual stopping thresholds and trial suspension rules address coagulation abnormalities, severe bleeding, severe liver injury, and other serious safety concerns. Blood samples will be used only for the planned study tests and will not be retained for unrelated future research.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 45 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →En Chu Kong Hospital is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: NRICM301
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.
Other: Placebo
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.
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.
Percentage of Participants With at Least One Adverse Event
Percentage of participants in the safety analysis set who experience at least one adverse event after the first dose of study product through the final follow-up visit. An adverse event is an unfavorable medical occurrence regardless of its causal relationship to the study product. The safety analysis set includes randomized participants who receive at least one dose. Event severity and relationship to the study product will also be summarized, and incidence will be compared between groups.
Time frame: From the first dose through Day 90 (plus or minus 7 days)
Percentage of Participants With at Least One Study Product-Related Adverse Reaction
Percentage of participants in the safety analysis set who experience at least one adverse reaction judged by the investigator to be related to the study product, from the first dose through the final follow-up visit. Causality is assessed using the protocol categories of not related, probably not related, possible, probable, and definite. Incidence will be compared between groups.
Time frame: From the first dose through Day 90 (plus or minus 7 days).
Percentage of Participants With at Least One Serious Adverse Event
Percentage of participants in the safety analysis set who experience at least one serious adverse event from the first dose through the final follow-up visit. Serious adverse events include death, life-threatening events, hospitalization or prolonged hospitalization, persistent disability or loss of function, congenital anomalies, or other medically important events. Incidence will be compared between groups regardless of causality.
Time frame: From the first dose through Day 90 (plus or minus 7 days).
Change From Baseline in National Institutes of Health Stroke Scale Score
Change in NIHSS total score from the pre-intervention baseline to each follow-up assessment, compared between groups. NIHSS scores range from 0 to 42, with higher scores indicating greater neurological impairment. Change is calculated as the follow-up score minus the baseline score; a negative change indicates improvement. Baseline assessment is performed at screening before study product administration.
Time frame: Baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Modified Rankin Scale Score
Change in modified Rankin Scale (mRS) score from the pre-dose baseline at Visit 2 to the final follow-up, compared between groups. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating a worse outcome. Change is calculated as the follow-up score minus the baseline score; negative, zero, and positive changes indicate improvement, no change, and worsening, respectively. Assessment may be conducted by telephone if an in-person visit is not possible.
Time frame: Pre-dose baseline and Day 90 (plus or minus 7 days).
Change From Baseline in Barthel Index Score
Change in Barthel Index score from the pre-dose baseline at Visit 2 to the final follow-up, compared between groups. The index assesses independence in activities of daily living, with higher scores indicating greater independence. Change is calculated as the follow-up score minus the baseline score; positive, zero, and negative changes indicate improvement, no change, and worsening, respectively. Assessment may be conducted by telephone if an in-person visit is not possible.
Time frame: Pre-dose baseline and Day 90 (plus or minus 7 days).
Hospital Length of Stay
Number of days spent in hospital during the study observation period, compared between groups. Hospital stays and reasons for readmission will be recorded at follow-up visits.
Time frame: Through Day 90 (plus or minus 7 days); reviewed at Days 7, 14, and 90.
Intensive Care Unit Length of Stay
Number of days spent in an intensive care unit during the study observation period, compared between groups. Intensive care admissions and their reasons will be recorded at follow-up visits.
Time frame: Through Day 90 (plus or minus 7 days); reviewed at Days 7, 14, and 90.
Change From Baseline in Interleukin-6 Concentration
Change in blood interleukin-6 (IL-6) concentration from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up concentration minus the baseline concentration. Samples will be analyzed by the National Research Institute of Chinese Medicine.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Tumor Necrosis Factor-alpha Concentration
Change in blood tumor necrosis factor-alpha (TNF-alpha) concentration from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up concentration minus the baseline concentration. Samples will be analyzed by the National Research Institute of Chinese Medicine.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline of Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change in Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Prothrombin Time
Change in prothrombin time (PT) from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Activated Partial Thromboplastin Time
Change in activated partial thromboplastin time (aPTT) from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in International Normalized Ratio
Change in prothrombin time international normalized ratio (INR), a dimensionless measure, from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Alanine Aminotransferase
Change in alanine aminotransferase (ALT) from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Aspartate Aminotransferase | Change in aspartate aminotransferase (AST) from
Change in aspartate aminotransferase (AST) from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Blood Urea Nitrogen
Change in blood urea nitrogen (BUN) from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Creatinine
Change in creatinine from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Blood Glucose
Change in blood glucose from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Percentage of Participants With Hemorrhagic Transformation
Percentage of participants with imaging-confirmed hemorrhagic transformation during follow-up.
Time frame: From the first dose through Day 90 (plus or minus 7 days).
Percentage of Participants With an Out-of-Range each Laboratory parameter
Percentage of participants with each parameter outside the laboratory reference range at each assessment.
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
correlation between changes in cytokine levels and changes in neurological function measures
Time frame: Days 7 and 14 (plus or minus 2 days for Day 14) against baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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En Chu Kong Hospital