Buyang Huanwu Decoction Combined With Wuling Powder as Adjunctive Therapy for Acute Ischemic Stroke: A Randomized, Assessor-Blinded, Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in National Institutes of Health Stroke Scale (NIHSS; 0-42) score from baseline to Day 14
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in National Institutes of Health Stroke Scale (NIHSS; 0-42) score from baseline to Day 14
时间窗: 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
Change in Barthel Index (0-100) score from baseline to Day 14
时间窗: 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.
Change in modified Rankin Scale (mRS; 0-6) score from baseline to Day 14
时间窗: 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.
次要结局
- Modified Rankin Scale Score at 90 Days After Stroke Onset(90 days after stroke onset)
- Incidence of Adverse Events During the Treatment Period(Baseline to Day 14)
- Change in serum MMP-9 (ng/mL) from baseline to Day 14(Baseline, Day 14)
- Change in serum superoxide dismutase (SOD; U/mL) from baseline to Day 14(Baseline, Day 14)
- Change in serum malondialdehyde (MDA; nmol/mL) from baseline to Day 14(Baseline, Day 14)
- Change in serum malondialdehyde (HO-1 (ng/mL)) from baseline to Day 14(Baseline, Day 14)
- Change in serum malondialdehyde (Keap1 (ng/mL)) from baseline to Day 14(Baseline, Day 14)
- Change in serum superoxide dismutase (NQO1 (ng/mL)) from baseline to Day 14(Baseline, Day 14)
- Change in serum malondialdehyde (Nrf2 (ng/mL)) from baseline to Day 14(Baseline, Day 14)
- Serum metabolomic profile changes from baseline to Day 14(Baseline, Day 14)
研究者
Changchuan Bai
Professor
Liaoning University of Traditional Chinese Medicine