Acute Ischemic StrokeNCT07902934
Safety of NRICM301 Added to Standard Care in Adults With Acute Ischemic Stroke
A study testing NRICM301 in people with Acute Ischemic Stroke, run by Tri-Service General Hospital (TSGH).
Trial summary
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. 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
- No sites listed yet
- 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 participants aged 20 years or older at screening.
- Acute ischemic stroke diagnosed by a physician based on clinical assessment and imaging, with a baseline National Institutes of Health Stroke Scale score of 5 to 22.
- Willingness to provide blood samples for stroke-related inflammatory cytokine testing.
- Ability to understand the study and willingness to provide written informed consent, or completion of the consent process with a person legally authorized to provide consent.
Who cannot join
- Receipt of, or planned treatment with, mechanical thrombectomy or intravenous thrombolysis with rt-PA or tenecteplase; or use within 7 days before screening or current use of other herbal medicines, including single-herb or multi-herb preparations, herbal injections or concentrated herbal preparations; supplements primarily containing herbs affecting coagulation or platelet function, such as Salvia miltiorrhiza, ginkgo, dong quai, turmeric or St. John's wort; or specified dietary supplements, including fish oil or omega-3 at more than 2 g/day, vitamin E at more than 400 IU/day, or garlic extracts.
- A prior stroke within the 7 days preceding onset of the current stroke, postoperative stroke, stroke due to a rare cause, or a prestroke modified Rankin Scale score of 4 or higher.
- Imaging evidence of intracranial hemorrhage or another nonischemic intracranial lesion; a cerebral arteriovenous malformation with a high bleeding risk; active abnormal bleeding or active bleeding; a history of a bleeding disorder or nontraumatic intracranial hemorrhage; or coagulation dysfunction or abnormal coagulation parameters considered clinically significant by a physician.
- Severe hepatic or renal impairment considered clinically significant by a physician, or pregnancy or breastfeeding based on participant self-report.
- Inability to accept a study product containing animal-derived food ingredients.
- Known allergy to Chi Shao, Chuan Xiong, Hong Qi or fish ingredients.
Show all 10Show fewer
- Participation within 3 months before screening in another interventional clinical trial involving a drug, biological product, herbal product or nutritional supplement with systemic physiological effects. Participation in a noninvasive medical device study, such as a blood pressure monitor or wearable monitor, may be permitted after principal investigator assessment. Purely behavioral, educational counseling, psychological assessment or cognitive training studies may also be permitted after principal investigator assessment if their interventions do not affect this study's outcomes or increase participation risk.
- Unwillingness or inability to comply with study procedures.
- Unwillingness or inability of the participant or the legally authorized person to provide written informed consent.
- Any other condition that may affect participant safety, assessment of clinical measures or interpretation of study results, or that makes participation inappropriate in the physician's professional judgment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on the Application of NRICM301 in Acute Ischemic Stroke: Observing the Safety and Application Status of a Food-Grade Herbal Formula
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.
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- NRICM301, Matching Placebo
- Keywords
- Acute Ischemic Stroke, NRICM301, Chinese herbal, Adjunctive therapy
- 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
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 PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NRICM301 Plus Standard Care | Experimental | 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. Receives: Dietary Supplement: NRICM301 |
| Matching Placebo Plus Standard Care | Placebo comparator | 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. Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first dose on Day 1 through Day 15
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the first dose on Day 1 through Day 91 (final visit window: +/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 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
- Treatment
- 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 receive study product for 14 consecutive days and are followed through Day 91. The target enrollment is 45 participants, with approximately 22 to 23 participants per arm. Block randomization with a block size of four will be used.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Institute of Chinese Medicine, Ministry of Health and Welfare
- Responsible party
- Principal investigator, Jui-Shan Lin, MD, Tri-Service General Hospital (TSGH)
- Investigators
- Yu-Hsin Chang, PhD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902934
- Sponsor's protocol ID
- XN-01
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Application of NRICM301 in Acute Ischemic Stroke: Observing the Safety and Application Status of a Food-Grade Herbal Formula
- ClinicalTrials.gov ID
- NCT07902934
- Acronym / sponsor ID
- XN-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, NRICM301, Chinese herbal, Adjunctive therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, 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
- 29 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, 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 receive study product for 14 consecutive days and are followed through Day 91. The target enrollment is 45 participants, with approximately 22 to 23 participants per arm. Block randomization with a block size of four will be used.
| Arm | Type | Receives |
|---|---|---|
| NRICM301 Plus Standard Care | Experimental | Dietary Supplement: NRICM301Participants 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. |
| Matching Placebo Plus Standard Care | Placebo comparator | Other: Matching PlaceboParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participants aged 20 years or older at screening.
- Acute ischemic stroke diagnosed by a physician based on clinical assessment and imaging, with a baseline National Institutes of Health Stroke Scale score of 5 to 22.
- Willingness to provide blood samples for stroke-related inflammatory cytokine testing.
- Ability to understand the study and willingness to provide written informed consent, or completion of the consent process with a person legally authorized to provide consent.
Key exclusion criteria (10 listed)
- Receipt of, or planned treatment with, mechanical thrombectomy or intravenous thrombolysis with rt-PA or tenecteplase; or use within 7 days before screening or current use of other herbal medicines, including single-herb or multi-herb preparations, herbal injections or concentrated herbal preparations; supplements primarily containing herbs affecting coagulation or platelet function, such as Salvia miltiorrhiza, ginkgo, dong quai, turmeric or St. John's wort; or specified dietary supplements, including fish oil or omega-3 at more than 2 g/day, vitamin E at more than 400 IU/day, or garlic extracts.
- A prior stroke within the 7 days preceding onset of the current stroke, postoperative stroke, stroke due to a rare cause, or a prestroke modified Rankin Scale score of 4 or higher.
- Imaging evidence of intracranial hemorrhage or another nonischemic intracranial lesion; a cerebral arteriovenous malformation with a high bleeding risk; active abnormal bleeding or active bleeding; a history of a bleeding disorder or nontraumatic intracranial hemorrhage; or coagulation dysfunction or abnormal coagulation parameters considered clinically significant by a physician.
- Severe hepatic or renal impairment considered clinically significant by a physician, or pregnancy or breastfeeding based on participant self-report.
- Inability to accept a study product containing animal-derived food ingredients.
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 |
|---|---|---|
| NRICM301NRICM301 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 | Dietary supplement | NRICM301 Plus Standard Care |
| Matching PlaceboMatching 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. | Other | Matching Placebo Plus Standard Care |
Primary outcome
Percentage of Participants With Study Product-Related Treatment-Emergent Adverse Events
Time frame: From the first dose on Day 1 through Day 15
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.
10 secondary outcomes
From the first dose on Day 1 through Day 15
Time frame: From the first dose on Day 1 through Day 15
Percentage of Participants With Serious Adverse Events Through Day 15
Time frame: From the first dose on Day 1 through Day 15
Percentage of Participants With Adverse Reactions Through Day 15
Time frame: From the first dose on Day 1 through Day 15
Percentage of Participants With Hemorrhagic Transformation Through Day 15
Time frame: From the first dose on Day 1 through Day 15
Percentage of Participants With Adverse Events Through Day 91
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
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
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
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
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
Time frame: From the first dose on Day 1 through Day 91 (final visit window: +/- 7 days)
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 29 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.
Yu-Hsin Chang, PhD principal investigator
Tri-Service General Hospital (TSGH)
Questions about this trial
What is this clinical trial studying?
A study testing NRICM301 in people with Acute Ischemic Stroke, run by Tri-Service General Hospital (TSGH).
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yu-Hsin Chang, PhD (+886-937-273-010, dan12489@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Study Product-Related Treatment-Emergent Adverse Events (time frame: From the first dose on Day 1 through Day 15). 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 29 Oct 2026.