Safety of adding NRICM301 to standard care for adults with acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This was a single-center, exploratory feasibility trial conducted at En Chu Kong Hospital in Taiwan. Adults with acute ischemic stroke and a baseline NIHSS of 5–22 are randomized 1:1 to receive NRICM301 or a matching placebo in addition to standard stroke care for 14 days. The study uses double-blind allocation with identical-looking drinks and concealed assignment, and follows participants for 90 days to monitor adverse events and functional outcomes. Safety, tolerability, and feasibility of integrating NRICM301 into acute stroke management are the primary focus, with informed consent managed by independent personnel. All participants continue standard stroke therapies, with adherence and outcomes tracked through visits or telephone assessments when needed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Where it's running

• En Chu Kong Hospital
  New Taipei City, Taiwan Recruiting

Study contacts

• Study coordinator: Chin-Hsien Chang
• Email: 01399@km.eck.org.tw
• Phone: +886-2-672-3456

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Short-Term outside-in nerve stimulation for acute ischemic stroke

  This trial tests whether a 5-day external trigeminal nerve stimulation given after stroke can help more patients recover better than a sham treatment.

  Recruiting Xidian University · Xi'an · NCT07911605

• Sevoflurane vs. Propofol for anesthesia in stroke patients undergoing clot-removal

  This study tests whether sevoflurane or propofol used for anesthesia during endovascular treatment of an acute ischemic stroke affects the final brain damage and recovery.

  Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07902791

• Intracranial Recanalization with LT3001 in Acute Ischemic Stroke

  This phase II study tests whether LT3001 given to adults with acute ischemic stroke can help reopen blocked brain arteries.

  Recruiting Phase 2 Lumosa Therapeutics Co., Ltd. · Taichung · NCT07890298

• Mobilisation After Endovascular Stroke Treatment

  This study checks whether moving around 12 hours after endovascular stroke treatment is as safe as moving around 24 hours for people with an acute ischemic stroke.

  Recruiting at 2 sites Karolinska Institutet · Tampere and 1 other locations · NCT07860333

• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

  In people with acute ischemic stroke due to distal or medium vessel blockages, this study tests whether adding endovascular treatment to the usual medical care helps improve outcomes compared with medical care alone.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT07843797

• Acute Ischemic Stroke in People with Active Cancer

  This study looks at how often people with active cancer have another ischemic stroke after an initial event, to see what factors might be linked to a recurrence.

  Recruiting Osaka University · Suita, Osaka · NCT07819526

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.