Acute Ischemic StrokeNCT07900503
Safety and Feasibility of NRICM301 Added to Usual Care for Adults With Acute Ischemic Stroke
A study testing NRICM301 in people with Acute Ischemic Stroke, run by En Chu Kong Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- NRICM301
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- Current pregnancy or breastfeeding.
- Inability to accept an intervention containing animal-derived ingredients.
Show all 11Show fewer
- Known allergy to Chi Shao, Chuan Xiong, Hong Qi, or fish ingredients in NRICM301.
- 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.
- Unwillingness or inability to comply with study procedures.
- Unwillingness or inability of the participant or a legally authorized representative to provide written informed consent.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
En Chu Kong Hospital
New Taipei City, 237
Chin-Hsien Chang, +886-2-2672-3456 ext. 3605, 01399@km.eck.org.tw
About this study
Official title: Evaluating the Clinical Integration of NRICM301, a Food-Grade Innovative Formula, in Acute Ischemic Stroke Care: Safety Observation and Feasibility Assessment
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.
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- NRICM301, Placebo
- Keywords
- NRICM301, Taiwan Xingnao No. 1, acute ischemic stroke, Chinese medicine, integrated traditional Chinese and Western medicine care
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRICM301Dietary supplement
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NRICM301 Plus Standard Care | Experimental | 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. Receives: Dietary Supplement: NRICM301 |
| Placebo Plus Standard Care | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From the first dose through Day 90 (plus or minus 7 days).
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to NRICM301 plus standard acute ischemic stroke care or matching placebo plus standard care. Both groups will receive the assigned study product for 14 consecutive days and will be followed through the 90-day visit. Randomization will use randomly mixed block sizes of four and six.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- En Chu Kong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Institute of Chinese Medicine, Ministry of Health and Welfare
- Responsible party
- Principal investigator, Chin-Hsien Chang, En Chu Kong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900503
- Sponsor's protocol ID
- ECKNR301
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Integration of NRICM301, a Food-Grade Innovative Formula, in Acute Ischemic Stroke Care: Safety Observation and Feasibility Assessment
- ClinicalTrials.gov ID
- NCT07900503
- Acronym / sponsor ID
- ECKNR301
- Conditions
- Acute Ischemic Stroke
- Keywords
- NRICM301, Taiwan Xingnao No. 1, acute ischemic stroke, Chinese medicine, integrated traditional Chinese and Western medicine care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- En Chu Kong HospitalUniversity, hospital or other
- Collaborators
- National Research Institute of Chinese Medicine, Ministry of Health and Welfare
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to NRICM301 plus standard acute ischemic stroke care or matching placebo plus standard care. Both groups will receive the assigned study product for 14 consecutive days and will be followed through the 90-day visit. Randomization will use randomly mixed block sizes of four and six.
| Arm | Type | Receives |
|---|---|---|
| NRICM301 Plus Standard Care | Experimental | Dietary Supplement: NRICM301Participants 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 Plus Standard Care | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
- 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.
- Current pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRICM301A 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. | Dietary supplement | NRICM301 Plus Standard Care |
| PlaceboA 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. | Other | Placebo Plus Standard Care |
Primary outcome
Percentage of Participants With at Least One Adverse Event
Time frame: From the first dose through Day 90 (plus or minus 7 days)
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.
Percentage of Participants With at Least One Study Product-Related Adverse Reaction
Time frame: From the first dose through Day 90 (plus or minus 7 days).
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.
Percentage of Participants With at Least One Serious Adverse Event
Time frame: From the first dose through Day 90 (plus or minus 7 days).
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.
16 secondary outcomes
Change From Baseline in National Institutes of Health Stroke Scale Score
Time frame: Baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Modified Rankin Scale Score
Time frame: Pre-dose baseline and Day 90 (plus or minus 7 days).
Change From Baseline in Barthel Index Score
Time frame: Pre-dose baseline and Day 90 (plus or minus 7 days).
Hospital Length of Stay
Time frame: Through Day 90 (plus or minus 7 days); reviewed at Days 7, 14, and 90.
Intensive Care Unit Length of Stay
Time frame: Through Day 90 (plus or minus 7 days); reviewed at Days 7, 14, and 90.
Change From Baseline in Interleukin-6 Concentration
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
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).
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Prothrombin Time
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
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
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Alanine Aminotransferase
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
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
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Creatinine
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Change From Baseline in Blood Glucose
Time frame: Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NRICM301 in people with Acute Ischemic Stroke, run by En Chu Kong Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chin-Hsien Chang (+886-2-672-3456 ext. 3605, 01399@km.eck.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least One Adverse Event (time frame: From the first dose through Day 90 (plus or minus 7 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.