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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Liaoning
-
Shenyang, Liaoning, China, 110034
- The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
Standard guideline-based medical care for acute ischemic stroke.
Guideline-based acute ischemic stroke management.
|
|
Experimental: 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.
|
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.
|
|
Comparador Falso: 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.
|
Blood samples collected for metabolomic profiling only.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in National Institutes of Health Stroke Scale (NIHSS; 0-42) score from baseline to Day 14
Prazo: Baseline and Day 14
|
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
|
|
Change in Barthel Index (0-100) score from baseline to Day 14
Prazo: Baseline and Day 14
|
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.
|
Baseline and Day 14
|
|
Change in modified Rankin Scale (mRS; 0-6) score from baseline to Day 14
Prazo: Baseline and Day 14
|
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.
|
Baseline and Day 14
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Modified Rankin Scale Score at 90 Days After Stroke Onset
Prazo: 90 days after stroke onset
|
The modified Rankin Scale was assessed at 90 days after stroke onset to evaluate longer-term functional outcome.
A lower score indicates less disability.
|
90 days after stroke onset
|
|
Incidence of Adverse Events During the Treatment Period
Prazo: Baseline to Day 14
|
Safety was assessed by monitoring adverse events during the treatment period.
The incidence, type, severity, duration, management, and outcome of adverse events were recorded.
|
Baseline to Day 14
|
|
Change in serum MMP-9 (ng/mL) from baseline to Day 14
Prazo: Baseline, Day 14
|
Serum MMP-9 levels were measured at baseline and Day 14 using ELISA.
|
Baseline, Day 14
|
|
Change in serum superoxide dismutase (SOD; U/mL) from baseline to Day 14
Prazo: Baseline, Day 14
|
Serum SOD levels were measured at baseline and Day 14 using ELISA.
|
Baseline, Day 14
|
|
Change in serum malondialdehyde (MDA; nmol/mL) from baseline to Day 14
Prazo: Baseline, Day 14
|
Serum MDA levels were measured at baseline and Day 14 using ELISA.
|
Baseline, Day 14
|
|
Change in serum malondialdehyde (HO-1 (ng/mL)) from baseline to Day 14
Prazo: Baseline, Day 14
|
Serum HO-1 levels were measured at baseline and Day 14 using ELISA.
|
Baseline, Day 14
|
|
Change in serum malondialdehyde (Keap1 (ng/mL)) from baseline to Day 14
Prazo: Baseline, Day 14
|
Serum Keap1 levels were measured at baseline and Day 14 using ELISA.
|
Baseline, Day 14
|
|
Change in serum superoxide dismutase (NQO1 (ng/mL)) from baseline to Day 14
Prazo: Baseline, Day 14
|
Serum NQO1 levels were measured at baseline and Day 14 using ELISA.
|
Baseline, Day 14
|
|
Change in serum malondialdehyde (Nrf2 (ng/mL)) from baseline to Day 14
Prazo: Baseline, Day 14
|
Serum Nrf2 levels were measured at baseline and Day 14 using ELISA.
|
Baseline, Day 14
|
|
Serum metabolomic profile changes from baseline to Day 14
Prazo: Baseline, Day 14
|
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.
|
Baseline, Day 14
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2023(XS)-001-02(FS)
- ethics committee (Identificador de registro: Universitary Hospital ethics committee of Marrakech)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .