Spatiotemporal Evolution of Traditional Chinese Medicine Mechanisms in Acute Ischemic Stroke Treated With Dengzhan Xixin and Dengzhan Shengmai (STEM-DZ)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prognosis; Ischemic Strokes; Traditional Chinese Medicine (TCM)
• Intervention / Treatment: Drug: corresponding control group sequential intervention; Drug: Dengzhan Shengmai - Erigeron breviscapus sequential intervention

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 Type: Interventional
• Enrollment (Estimated): 358
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. 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
3. Within 48 hours after the first onset
4. National Institutes of Health Stroke Scale (NIHSS) score ranging from 4 to 25 points
5. Voluntarily signed informed consent.

Exclusion Criteria:

1. Pre-stroke modified Rankin Scale (mRS) score ≥ 2
2. Patients with transient ischemic attack (TIA), complicated with cerebral hemorrhage or subarachnoid hemorrhage
3. patients with brain tumor, Alzheimer's disease, psychosis, or a confirmed diagnosis of dementia
4. Patients undergoing endovascular thrombectomy
5. 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
6. 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
7. Patients with a history of allergy to the study drug or preparations containing the same ingredients
8. Pregnant or lactating women
9. Patients judged by the investigators as unsuitable for participation in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: corresponding control group sequential intervention; 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.
Experimental: treatment group; 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.	Drug: Dengzhan Shengmai - Erigeron breviscapus sequential intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	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.	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The differences in scores on the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) between the two groups at 6 months.	The differences in scores on the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) between the two groups at 6 months.	180 days
The difference in the Activities of Daily Living (ADL) scale scores between the two groups at 6 months.	The difference in the Activities of Daily Living (ADL) scale scores between the two groups at 6 months.	180 days
All-cause mortality and recurrence rate of cardiovascular events in both groups were followed up until death or 6 months after treatment.	All-cause mortality and recurrence rate of cardiovascular and cerebrovascular events in both groups followed until death or 6 months after treatment.	180 days

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Collaborators: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Traditional Chinese Medicine (TCM); Dianzhizhengmai Capsules; Dengzhanxixin Injection
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: BF2025-229-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No