Ischemic StrokesPhase 2/3STEM-DZNCT07591883
Spatiotemporal Evolution of Traditional Chinese Medicine Mechanisms in Acute Ischemic Stroke Treated With Dengzhan Xixin and Dengzhan Shengmai
A Phase 2/3 study testing Dengzhan Shengmai - Erigeron breviscapus sequential intervention in people with Ischemic Strokes and Traditional Chinese Medicine (TCM), run by Guangdong Provincial Hospital of Traditional Chinese Medicine.
Trial summary
To integrate large-scale RCT data on clinical symptoms, TCM syndromes, prognosis, and multi-omics profiles, construct a spatiotemporal dynamic network for disease-syndrome evolution of acute ischemic stroke (AIS) in the acute and recovery phases, evaluate the efficacy and safety of sequential treatment with Erigeron… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Strokes, Traditional Chinese Medicine (TCM), Prognosis
- What is being tested?
- Dengzhan Shengmai - Erigeron breviscapus sequential intervention
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 358 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Jul 2029
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Meeting the diagnostic criteria for acute ischemic stroke in accordance with the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2023
- Within 48 hours after the first onset
- National Institutes of Health Stroke Scale (NIHSS) score ranging from 4 to 25 points
- Voluntarily signed informed consent.
Who cannot join
- Pre-stroke modified Rankin Scale (mRS) score ≥ 2
- Patients with transient ischemic attack (TIA), complicated with cerebral hemorrhage or subarachnoid hemorrhage
- patients with brain tumor, Alzheimer's disease, psychosis, or a confirmed diagnosis of dementia
- Patients undergoing endovascular thrombectomy
- Patients with severe cardiac diseases such as valvular heart disease, infective endocarditis, myocardial infarction, heart failure, severe hepatic or renal insufficiency, respiratory failure, malignant tumor, or massive gastrointestinal hemorrhage
- Patients who have used any preparations containing the same ingredients as the study drug (e.g., Erigeron breviscapus, ginseng, dwarf lilyturf tuber, schisandra chinensis, etc.) within the past 2 weeks
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- Patients with a history of allergy to the study drug or preparations containing the same ingredients
- Pregnant or lactating women
- Patients judged by the investigators as unsuitable for participation in this trial.
About this study
To integrate large-scale RCT data on clinical symptoms, TCM syndromes, prognosis, and multi-omics profiles, construct a spatiotemporal dynamic network for disease-syndrome evolution of acute ischemic stroke (AIS) in the acute and recovery phases, evaluate the efficacy and safety of sequential treatment with Erigeron breviscapus-Dengzhan Shengmai for AIS, and provide evidence for precise syndrome differentiation and individualized therapy.Secondary Objective:To investigate the optimal time window and key intervention targets of sequential treatment with Erigeron breviscapus-Dengzhan Shengmai for AIS.
Read the detailed description
This study is a randomized (1:1), double - blind, multicenter, parallel - controlled clinical trial. It plans to recruit 358 patients with acute ischemic stroke (AIS). The research period is 3 months. After the blind is unmasked in the third month, an exploratory clinical study will be carried out and the patients will be observed for 6 months. The purpose of the study is to explore the spatio - temporal evolution law, efficacy, and safety of the sequential treatment of AIS with "Erigeron breviscapus - Dengzhan Shengmai". After all the selected patients sign the informed consent form and meet the inclusion/exclusion criteria, they will be randomly assigned to the experimental group or the control group at a ratio of 1:1 through the central randomization system (IWRS):
Experimental group:
Acute phase (0 - 7 days after onset): 40 mL of Erigeron breviscapus injection diluted with 250 mL of normal saline, administered by intravenous drip once a day; Recovery phase (8 - 90 days): 2 capsules of Dengzhan Shengmai capsules (0.18 g per capsule), taken orally three times a day.
Control group:
Acute phase (0 - 7 days after onset): 250 mL of normal saline, administered by intravenous drip once a day; Recovery phase (8 - 90 days): 2 placebo capsules (starch, 0.18 g per capsule), taken orally three times a day.
All groups will receive basic treatment, including anti - platelet (aspirin/clopidogrel), blood pressure, blood lipid, and blood glucose control and other relevant treatments as stipulated in the guidelines.
Safety and compliance assessments will be conducted at the first administration and in the first week of treatment; researchers will also provide medication guidance. Subsequently, safety assessments and follow - ups will be carried out at 30±7 days and 90±7 days; efficacy assessments and follow - ups will be carried out at 48 hours, 7 days, 30±7 days, 90±7 days, and 180±7 days.
- Being tested
- Dengzhan Shengmai - Erigeron breviscapus sequential intervention, corresponding control group sequential intervention
- Keywords
- Ischemic Stroke, Traditional Chinese Medicine (TCM), Dianzhizhengmai Capsules, Dengzhanxixin Injection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dengzhan Shengmai - Erigeron breviscapus sequential interventionDrug
Trial group:
Acute phase (0-7 days after onset): Breviscapine of Dengzhan Xixin injection 40 mL diluted with 250 mL normal saline, intravenous drip, once daily.
Recovery phase (8-90 days): Dengzhan Shengmai capsules 0.18 g/capsule × 2 capsules, orally, three times daily.
corresponding control group sequential interventionDrug
Control group:
Acute phase (0-7 days after onset): Normal saline 250 mL, intravenous drip, once daily.
Recovery phase (8-90 days): Placebo capsules (starch) 0.18 g/capsule × 2 capsules, orally, three times daily.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Acute phase (0-7 days after onset): Normal saline 250 mL, intravenous drip, once daily.
Recovery phase (8-90 days): Placebo capsules (starch) 0.18 g/capsule × 2 capsules, orally, three times daily. Receives: Drug: corresponding control group sequential intervention |
| treatment group | Experimental | Trial group:
Acute phase (0-7 days after onset): Breviscapine injection 40 mL diluted with 250 mL normal saline, intravenous drip, once daily.
Recovery phase (8-90 days): Dengzhan Shengmai capsules 0.18 g/capsule × 2 capsules, orally, three times daily. Receives: Drug: Dengzhan Shengmai - Erigeron breviscapus sequential intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months in the treatment group versus the control group.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months in the treatment group versus the control group.
Measured: 90 days
Secondary outcomes (6)
The difference in the change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 3 months between the two groups.
The difference in the change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 3 months between the two groups.
Measured: 90 days
Distribution of modified Rankin Scale (mRS) scores in both groups at 3 months.
Distribution of modified Rankin Scale (mRS) scores in both groups at 3 months.
Measured: 90 days
Incidence of symptomatic intracerebral hemorrhage events within 7 days in both groups.
Incidence of symptomatic intracerebral hemorrhage events within 7 days in both groups.
Measured: 7 days
Incidence of early neurological deterioration events within 7 days in both groups (defined as: an increase of ≥2 points in the NIHSS scores reflecting motor function and consciousness, or an increase of ≥4 points in the total NIHSS score within 7 days).
Incidence of early neurological deterioration events within 7 days in both groups (defined as: an increase of ≥2 points in the NIHSS scores reflecting motor function and consciousness, or an increase of ≥4 points in the total NIHSS score within 7 days).
Measured: 7 days
Differences in scores of the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Activities of Daily Living (ADL) scale between the two groups at 3 months.
Differences in scores of the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Activities of Daily Living (ADL) scale between the two groups at 3 months.
Measured: 90 days
The all-cause mortality rate and recurrence rate of cardiovascular and cerebrovascular events were compared between the two groups at follow-up until death or 3 months after treatment.
The all-cause mortality rate and recurrence rate of cardiovascular and cerebrovascular events were compared between the two groups at follow-up until death or 3 months after treatment.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University
- Responsible party
- Principal investigator, Cheng xiao, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591883
- Sponsor's protocol ID
- BF2025-229-01
- Acronym
- STEM-DZ
- Status last verified
- Apr 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatiotemporal Evolution of Traditional Chinese Medicine Mechanisms in Acute Ischemic Stroke Treated With Dengzhan Xixin and Dengzhan Shengmai
- ClinicalTrials.gov ID
- NCT07591883
- Acronym / sponsor ID
- STEM-DZ / BF2025-229-01
- Keywords
- Ischemic Stroke, Traditional Chinese Medicine (TCM), Dianzhizhengmai Capsules, Dengzhanxixin Injection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 18 May 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.
To integrate large-scale RCT data on clinical symptoms, TCM syndromes, prognosis, and multi-omics profiles, construct a spatiotemporal dynamic network for disease-syndrome evolution of acute ischemic stroke (AIS) in the acute and recovery phases, evaluate the efficacy and safety of sequential treatment with Erigeron breviscapus-Dengzhan Shengmai for AIS, and provide evidence for precise syndrome differentiation and individualized therapy.Secondary Objective:To investigate the optimal time window and key intervention targets of sequential treatment with Erigeron breviscapus-Dengzhan Shengmai for AIS.
Detailed description
This study is a randomized (1:1), double - blind, multicenter, parallel - controlled clinical trial. It plans to recruit 358 patients with acute ischemic stroke (AIS). The research period is 3 months. After the blind is unmasked in the third month, an exploratory clinical study will be carried out and the patients will be observed for 6 months. The purpose of the study is to explore the spatio - temporal evolution law, efficacy, and safety of the sequential treatment of AIS with "Erigeron breviscapus - Dengzhan Shengmai". After all the selected patients sign the informed consent form and meet the inclusion/exclusion criteria, they will be randomly assigned to the experimental group or the control group at a ratio of 1:1 through the central randomization system (IWRS):
Experimental group:
Acute phase (0 - 7 days after onset): 40 mL of Erigeron breviscapus injection diluted with 250 mL of normal saline, administered by intravenous drip once a day; Recovery phase (8 - 90 days): 2 capsules of Dengzhan Shengmai capsules (0.18 g per capsule), taken orally three times a day.
Control group:
Acute phase (0 - 7 days after onset): 250 mL of normal saline, administered by intravenous drip once a day; Recovery phase (8 - 90 days): 2 placebo capsules (starch, 0.18 g per capsule), taken orally three times a day.
All groups will receive basic treatment, including anti - platelet (aspirin/clopidogrel), blood pressure, blood lipid, and blood glucose control and other relevant treatments as stipulated in the guidelines.
Safety and compliance assessments will be conducted at the first administration and in the first week of treatment; researchers will also provide medication guidance. Subsequently, safety assessments and follow - ups will be carried out at 30±7 days and 90±7 days; efficacy assessments and follow - ups will be carried out at 48 hours, 7 days, 30±7 days, 90±7 days, and 180±7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: corresponding control group sequential interventionAcute phase (0-7 days after onset): Normal saline 250 mL, intravenous drip, once daily. Recovery phase (8-90 days): Placebo capsules (starch) 0.18 g/capsule × 2 capsules, orally, three times daily. |
| treatment group | Experimental | Drug: Dengzhan Shengmai - Erigeron breviscapus sequential interventionTrial group: Acute phase (0-7 days after onset): Breviscapine injection 40 mL diluted with 250 mL normal saline, intravenous drip, once daily. Recovery phase (8-90 days): Dengzhan Shengmai capsules 0.18 g/capsule × 2 capsules, orally, three times daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Meeting the diagnostic criteria for acute ischemic stroke in accordance with the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2023
- Within 48 hours after the first onset
- National Institutes of Health Stroke Scale (NIHSS) score ranging from 4 to 25 points
- Voluntarily signed informed consent.
Key exclusion criteria (9 listed)
- Pre-stroke modified Rankin Scale (mRS) score ≥ 2
- Patients with transient ischemic attack (TIA), complicated with cerebral hemorrhage or subarachnoid hemorrhage
- patients with brain tumor, Alzheimer's disease, psychosis, or a confirmed diagnosis of dementia
- Patients undergoing endovascular thrombectomy
- Patients with severe cardiac diseases such as valvular heart disease, infective endocarditis, myocardial infarction, heart failure, severe hepatic or renal insufficiency, respiratory failure, malignant tumor, or massive gastrointestinal hemorrhage
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 |
|---|---|---|
| Dengzhan Shengmai - Erigeron breviscapus sequential interventionTrial group: Acute phase (0-7 days after onset): Breviscapine of Dengzhan Xixin injection 40 mL diluted with 250 mL normal saline, intravenous drip, once daily. Recovery phase (8-90 days): Dengzhan Shengmai capsules 0.18 g/capsule × 2 capsules, orally, three times daily. | Drug | treatment group |
| corresponding control group sequential interventionControl group: Acute phase (0-7 days after onset): Normal saline 250 mL, intravenous drip, once daily. Recovery phase (8-90 days): Placebo capsules (starch) 0.18 g/capsule × 2 capsules, orally, three times daily. | Drug | control group |
Primary outcome
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months in the treatment group versus the control group.
Time frame: 90 days
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months in the treatment group versus the control group.
6 secondary outcomes
The difference in the change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 3 months between the two groups.
Time frame: 90 days
Distribution of modified Rankin Scale (mRS) scores in both groups at 3 months.
Time frame: 90 days
Incidence of symptomatic intracerebral hemorrhage events within 7 days in both groups.
Time frame: 7 days
Incidence of early neurological deterioration events within 7 days in both groups (defined as: an increase of ≥2 points in the NIHSS scores reflecting motor function and consciousness, or an increase of ≥4 points in the total NIHSS score within 7 days).
Time frame: 7 days
Differences in scores of the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Activities of Daily Living (ADL) scale between the two groups at 3 months.
Time frame: 90 days
The all-cause mortality rate and recurrence rate of cardiovascular and cerebrovascular events were compared between the two groups at follow-up until death or 3 months after treatment.
Time frame: 90 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 18 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dengzhan Shengmai - Erigeron breviscapus sequential intervention in people with Ischemic Strokes and Traditional Chinese Medicine (TCM), run by Guangdong Provincial Hospital of Traditional Chinese Medicine.
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 5 inclusion and 9 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 18 May 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months in the treatment group versus the control group. (time frame: 90 days). 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 18 May 2026.