An interventional study of NRICM301 and Matching Placebo in Acute Ischemic Stroke, sponsored by Tri-Service General Hospital (TSGH). Not yet recruiting. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Tri-Service General Hospital (TSGH) · Not applicable, Interventional, and Treatment
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.
This single-center, randomized, placebo-controlled, parallel-group study evaluates adjunctive NRICM301 during standard acute ischemic stroke care. An independent statistician will generate a 1:1 allocation sequence using block randomization with a block size of four. The manufacturer will package and label study products according to the allocation sequence. NRICM301 and placebo will have closely matched appearance, packaging, color, and odor. Allocation information will be held by designated personnel independent of recruitment, study conduct, and outcome assessment. Emergency unmasking is permitted only when knowledge of treatment assignment is essential for urgent medical management, as specified in the protocol.
After clinical stabilization, the informed consent process will be conducted by study personnel who are not the physicians providing the potential participant's first-line emergency treatment. Baseline assessments must be completed before the first study dose. Clinical assessments are performed by physicians separate from those providing study-related clinical care. Participants discharged during the intervention period will receive the remaining study product and dosing records, with telephone reminders. Product accountability and dosing records will be used to assess adherence. Telephone assessment may be used for the final functional follow-up if an in-person visit is not feasible.
Safety analyses will include randomized participants who receive at least one dose and will use actual treatment received. Exploratory clinical analyses will use a modified intention-to-treat population, with a per-protocol analysis as supportive. The sample size is based on exploratory safety estimation and the commissioned study target, rather than a confirmatory efficacy power calculation. Analyses will primarily use observed data without routine single or multiple imputation. Missingness and reasons for missing data will be reported, with sensitivity analyses where appropriate. No formal statistical interim analysis is planned. An internal safety monitoring group will review accumulating safety data and apply the protocol-defined stopping criteria. No independent data and safety monitoring board is planned.
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 →Tri-Service General Hospital (TSGH) is the lead sponsor of 38 studies on the registry; 12 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.
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive NRICM301, 100 mL twice daily for 14 consecutive days, in addition to standard acute ischemic stroke care. Each dose consists of two 50-mL sachets and is administered orally or through a nasogastric tube. The first dose is given within 24 hours after hospital arrival. Standard care includes clinically indicated antiplatelet treatment, blood pressure and glucose management, and rehabilitation assessment.
Dietary Supplement: NRICM301
Participants receive matching placebo, 100 mL twice daily for 14 consecutive days, in addition to standard acute ischemic stroke care. Each dose consists of two 50-mL sachets and is administered orally or through a nasogastric tube. The first dose is given within 24 hours after hospital arrival. The placebo closely matches NRICM301 in appearance, color, odor, packaging, and volume. Standard care is provided as in the experimental arm.
Other: Matching Placebo
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
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.
Percentage of Participants With Study Product-Related Treatment-Emergent Adverse Events
The percentage of participants with at least one treatment-emergent adverse event (TEAE) assessed as possibly, probably, or definitely related to the study product will be compared between groups. A TEAE is an event that starts after the first dose or a pre-existing symptom, disease, or laboratory abnormality that worsens after the first dose. Relatedness is assessed by the study physician. The safety population includes randomized participants who receive at least one dose, analyzed according to actual treatment received.
Time frame: From the first dose on Day 1 through Day 15
From the first dose on Day 1 through Day 15
The percentage of participants with at least one TEAE, regardless of relatedness to study product, will be compared between groups. TEAEs include new events after the first dose and worsening of pre-existing conditions or laboratory abnormalities after the first dose.
Time frame: From the first dose on Day 1 through Day 15
Percentage of Participants With Serious Adverse Events Through Day 15
The percentage of participants with at least one serious adverse event will be compared between groups. Serious events include death, life-threatening events, hospitalization or prolonged hospitalization, persistent disability, congenital anomalies, or other medically important events.
Time frame: From the first dose on Day 1 through Day 15
Percentage of Participants With Adverse Reactions Through Day 15
The percentage of participants with at least one adverse reaction assessed as possibly, probably, or definitely related to study product will be compared between groups. Relatedness will be assessed by the study physician.
Time frame: From the first dose on Day 1 through Day 15
Percentage of Participants With Hemorrhagic Transformation Through Day 15
The percentage of participants with hemorrhagic transformation of the ischemic stroke will be compared between groups. Imaging confirmation and hemorrhage classification will be recorded, including hemorrhagic infarction and parenchymal hematoma categories, with symptomatic status recorded.
Time frame: From the first dose on Day 1 through Day 15
Percentage of Participants With Adverse Events Through Day 91
The number and percentage of participants with at least one adverse event, regardless of its relationship to the study product will be summarized by group. Event timing, severity, relatedness, and outcomes will be recorded as applicable. Exploratory between-group comparisons may be performed.
Time frame: From the first dose on Day 1 through Day 91 (final visit window: +/- 7 days)
Percentage of Participants With Serious Adverse Events Through Day 91
The number and percentage of participants with at least one serious adverse event, regardless of its relationship to the study product will be summarized by group. Event timing, severity, relatedness, and outcomes will be recorded as applicable. Exploratory between-group comparisons may be performed.
Time frame: From the first dose on Day 1 through Day 91 (final visit window: +/- 7 days)
Percentage of Participants With Death Through Day 91
The number and percentage of participants with death from any cause will be summarized by group. Event timing, severity, relatedness, and outcomes will be recorded as applicable. Exploratory between-group comparisons may be performed.
Time frame: From the first dose on Day 1 through Day 91 (final visit window: +/- 7 days)
Percentage of Participants With Recurrent Stroke Through Day 91
The number and percentage of participants with a recurrent stroke event will be summarized by group. Event timing, severity, relatedness, and outcomes will be recorded as applicable. Exploratory between-group comparisons may be performed.
Time frame: From the first dose on Day 1 through Day 91 (final visit window: +/- 7 days)
Percentage of Participants With Hemorrhagic Transformation Through Day 91
The number and percentage of participants with hemorrhagic transformation of the ischemic stroke, documented with imaging findings will be summarized by group. Event timing, severity, relatedness, and outcomes will be recorded as applicable. Exploratory between-group comparisons may be performed.
Time frame: From the first dose on Day 1 through Day 91 (final visit window: +/- 7 days)
Percentage of Participants With Other Clinically Important Events Through Day 91
The number and percentage of participants with another clinically important event documented by the study physician will be summarized by group. Event timing, severity, relatedness, and outcomes will be recorded as applicable. Exploratory between-group comparisons may be performed.
Time frame: From the first dose on Day 1 through Day 91 (final visit window: +/- 7 days)
No study locations are listed for this record.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Tri-Service General Hospital (TSGH)