Spatiotemporal Evolution of Traditional Chinese Medicine Mechanisms in Acute Ischemic Stroke Treated With Dengzhan Xixin and Dengzhan Shengmai

NCT07591883 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: BF2025-229-01
• Study Type: interventional
• Target: 358
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Ischemic Strokes; Prognosis; Traditional Chinese Medicine (TCM)

Keywords

Ischemic Stroke; Traditional Chinese Medicine (TCM); Dianzhizhengmai Capsules; Dengzhanxixin Injection

Outcome Measures

Primary Outcomes (1)

• 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 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.

  90 days

• 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.

  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.

  90 days

Other Outcomes (3)

• 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.

  180 days

• All-cause mortality and recurrence rate of cardiovascular events in both groups were followed up until death or 6 months after treatment.

  180 days

Study Arms (2)

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.

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.

Drug: Dengzhan Shengmai - Erigeron breviscapus sequential intervention

Interventions

Dengzhan Shengmai - Erigeron breviscapus sequential intervention DRUG

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.

treatment group

corresponding control group sequential intervention DRUG

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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead
• Nanfang Hospital, Southern Medical University: collaborator

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-04