Buyang Huanwu Decoction With Wuling Powder for Acute Ischemic Stroke (BYHW-WL)
Buyang Huanwu Decoction Combined With Wuling Powder as Adjunctive Therapy for Acute Ischemic Stroke: A Randomized, Assessor-Blinded, Controlled Clinical Study
Acute ischemic stroke is a common cause of disability. Standard Western medical treatment is widely used, but some patients continue to have neurological impairment and difficulty with daily activities after stroke.
This study evaluated whether Buyang Huanwu Decoction combined with Wuling Powder, when added to standard Western medical treatment, could help improve recovery in patients with acute ischemic stroke. Eligible patients were randomly assigned to receive either standard Western medical treatment alone or standard Western medical treatment plus Buyang Huanwu Decoction combined with Wuling Powder for 14 days.
The study assessed neurological function, activities of daily living, disability outcomes, and short-term safety. Blood samples were also collected to explore changes in serum metabolites and redox-related biomarkers that may be related to treatment response. A non-stroke reference group was included only for serum metabolomic comparison and was not part of the randomized treatment comparison.
Přehled studie
Postavení
Podmínky
Detailní popis
This single-center, randomized, assessor-blinded, controlled clinical study was designed to evaluate Buyang Huanwu Decoction combined with Wuling Powder as an adjunct to standard Western medical treatment in patients with acute ischemic stroke.
Eligible patients with acute ischemic stroke were randomly assigned to receive standard Western medical treatment alone or standard Western medical treatment plus Buyang Huanwu Decoction combined with Wuling Powder for 14 days. Because the intervention involved an oral herbal decoction, participant blinding was not feasible. Clinical outcome assessors, laboratory technicians, and metabolomics analysts were blinded to group allocation.
The clinical part of the study focused on neurological function, activities of daily living, disability outcomes, and short-term safety. These were assessed using the National Institutes of Health Stroke Scale, Barthel Index, modified Rankin Scale, and adverse event monitoring.
The exploratory mechanistic part of the study examined serum drug-derived constituents, untargeted serum metabolomic profiles, and redox-related biomarkers. Serum samples were collected from patients with acute ischemic stroke before and after treatment. A non-stroke reference group provided serum samples for metabolomic comparison only and was not included in the randomized treatment comparison.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Liaoning
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Shenyang, Liaoning, Čína, 110034
- The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Clinical diagnosis of acute ischemic stroke confirmed by CT or MRI Age 40-75 years (stroke group) Age 20-75 years (non-stroke reference group) Enrollment within 7 days of symptom onset NIHSS score 4-22 mRS score 2-4 First-ever ischemic stroke or prior infarction without baseline disability No intravenous thrombolysis, thrombectomy, or vascular stenting Written informed consent obtained
Exclusion Criteria:
Transient ischemic attack or hemorrhagic stroke Subarachnoid hemorrhage or vascular malformation Lacunar infarction or large infarction with severe edema Non-atherothrombotic stroke causes (tumor, trauma, metabolic, parasitic, rheumatic heart disease) Severe cardiac, hepatic, renal, hematologic, or endocrine disease Severe psychiatric or cognitive impairment Severe physical disability affecting evaluation Pregnancy or lactation Drug allergy or bleeding tendency Participation in other clinical trials within 4 weeks Progressive stroke Use of organ-damaging drugs within 4 weeks
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Standard Western Medical Treatment
Participants received standard Western medical treatment for acute ischemic stroke according to clinical guidelines, including antiplatelet therapy, lipid-lowering therapy, plaque stabilization, neuroprotective treatment, and management of blood pressure and blood glucose.
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Standard guideline-based medical care for acute ischemic stroke.
Guideline-based acute ischemic stroke management.
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Experimentální: Buyang Huanwu Decoction Combined With Wuling Powder Plus Standard Western Medical Treatment
Participants received Buyang Huanwu Decoction combined with Wuling Powder in addition to standard Western medical treatment for 14 days.
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Standard guideline-based medical care for acute ischemic stroke.
Guideline-based acute ischemic stroke management.
14-day oral decoction, twice daily, composed of Astragali Radix, Angelicae Sinensis Radix, and other herbs as specified.
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Falešný srovnávač: Non-Stroke Metabolomic Reference Group
Participants provided serum samples only for metabolomic comparison and did not receive any therapeutic intervention.
This group was not part of the randomized treatment allocation.
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Blood samples collected for metabolomic profiling only.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in National Institutes of Health Stroke Scale (NIHSS; 0-42) score from baseline to Day 14
Časové okno: Baseline and Day 14
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The National Institutes of Health Stroke Scale was used to assess neurological deficit severity in patients with acute ischemic stroke. Scores were assessed before treatment and after 14 days of treatment. A lower score indicates less severe neurological impairment. Scale: 0-42 Higher score = worse neurological deficit Lower score = improvement |
Baseline and Day 14
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Change in Barthel Index (0-100) score from baseline to Day 14
Časové okno: Baseline and Day 14
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Range: 0-100 Higher score = better activities of daily living The Barthel Index was used to assess activities of daily living in patients with acute ischemic stroke.
Scores were assessed before treatment and after 14 days of treatment.
A higher score indicates better ability to perform activities of daily living.
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Baseline and Day 14
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Change in modified Rankin Scale (mRS; 0-6) score from baseline to Day 14
Časové okno: Baseline and Day 14
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Range: 0-6 Higher score = worse disability The modified Rankin Scale was used to assess disability outcome in patients with acute ischemic stroke.
Scores were assessed before treatment and after 14 days of treatment.
A lower score indicates less disability.
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Baseline and Day 14
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Modified Rankin Scale Score at 90 Days After Stroke Onset
Časové okno: 90 days after stroke onset
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The modified Rankin Scale was assessed at 90 days after stroke onset to evaluate longer-term functional outcome.
A lower score indicates less disability.
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90 days after stroke onset
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Incidence of Adverse Events During the Treatment Period
Časové okno: Baseline to Day 14
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Safety was assessed by monitoring adverse events during the treatment period.
The incidence, type, severity, duration, management, and outcome of adverse events were recorded.
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Baseline to Day 14
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Change in serum MMP-9 (ng/mL) from baseline to Day 14
Časové okno: Baseline, Day 14
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Serum MMP-9 levels were measured at baseline and Day 14 using ELISA.
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Baseline, Day 14
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Change in serum superoxide dismutase (SOD; U/mL) from baseline to Day 14
Časové okno: Baseline, Day 14
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Serum SOD levels were measured at baseline and Day 14 using ELISA.
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Baseline, Day 14
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Change in serum malondialdehyde (MDA; nmol/mL) from baseline to Day 14
Časové okno: Baseline, Day 14
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Serum MDA levels were measured at baseline and Day 14 using ELISA.
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Baseline, Day 14
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Change in serum malondialdehyde (HO-1 (ng/mL)) from baseline to Day 14
Časové okno: Baseline, Day 14
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Serum HO-1 levels were measured at baseline and Day 14 using ELISA.
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Baseline, Day 14
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Change in serum malondialdehyde (Keap1 (ng/mL)) from baseline to Day 14
Časové okno: Baseline, Day 14
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Serum Keap1 levels were measured at baseline and Day 14 using ELISA.
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Baseline, Day 14
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Change in serum superoxide dismutase (NQO1 (ng/mL)) from baseline to Day 14
Časové okno: Baseline, Day 14
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Serum NQO1 levels were measured at baseline and Day 14 using ELISA.
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Baseline, Day 14
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Change in serum malondialdehyde (Nrf2 (ng/mL)) from baseline to Day 14
Časové okno: Baseline, Day 14
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Serum Nrf2 levels were measured at baseline and Day 14 using ELISA.
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Baseline, Day 14
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Serum metabolomic profile changes from baseline to Day 14
Časové okno: Baseline, Day 14
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Serum metabolomic profiles were analyzed using ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry.
Untargeted metabolomics was used to evaluate treatment-associated metabolic changes.
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Baseline, Day 14
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2023(XS)-001-02(FS)
- ethics committee (Identifikátor registru: Universitary Hospital ethics committee of Marrakech)
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