Spatiotemporal Evolution of Traditional Chinese Medicine Mechanisms in Acute Ischemic Stroke Treated With Dengzhan Xixin and Dengzhan Shengmai (STEM-DZ)
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
- Fáze 3
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: 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. |
|
Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months in the treatment group versus the control group.
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The difference in the change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 3 months between the two groups.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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).
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The differences in scores on the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) between the two groups at 6 months.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BF2025-229-01
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