Spatiotemporal Evolution of Traditional Chinese Medicine Mechanisms in Acute Ischemic Stroke Treated With Dengzhan Xixin and Dengzhan Shengmai (STEM-DZ)
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 3
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: 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: 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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months in the treatment group versus the control group.
Periodo de tiempo: 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.
|
90 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The difference in the change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 3 months between the two groups.
Periodo de tiempo: 90 days
|
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.
Periodo de tiempo: 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.
Periodo de tiempo: 7 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).
Periodo de tiempo: 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.
Periodo de tiempo: 90 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
|
|
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.
Periodo de tiempo: 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.
|
90 days
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The differences in scores on the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) between the two groups at 6 months.
Periodo de tiempo: 180 days
|
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.
Periodo de tiempo: 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.
Periodo de tiempo: 180 days
|
All-cause mortality and recurrence rate of cardiovascular and cerebrovascular events in both groups followed until death or 6 months after treatment.
|
180 days
|
Colaboradores e Investigadores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BF2025-229-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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