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NCT Number: NCT07687043

Buyang Huanwu Decoction With Wuling Powder for Acute Ischemic Stroke

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, 110034, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Western Medical Treatment

Procedure

Standard guideline-based medical care for acute ischemic stroke.

Serum Sample Collection for Metabolomics Only

Other

Blood samples collected for metabolomic profiling only.

Buyang Huanwu Decoction Combined With Wuling Powder

Drug

14-day oral decoction, twice daily, composed of Astragali Radix, Angelicae Sinensis Radix, and other herbs as specified.

Primary outcomes

  1. Change in National Institutes of Health Stroke Scale (NIHSS; 0-42) score from baseline to Day 14

    Time frame: 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

  2. Change in Barthel Index (0-100) score from baseline to Day 14

    Time frame: 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.

  3. Change in modified Rankin Scale (mRS; 0-6) score from baseline to Day 14

    Time frame: 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.

Secondary outcomes

  1. Modified Rankin Scale Score at 90 Days After Stroke Onset

    Time frame: 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.

  2. Incidence of Adverse Events During the Treatment Period

    Time frame: 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.

  3. Change in serum MMP-9 (ng/mL) from baseline to Day 14

    Time frame: Baseline, Day 14

    Serum MMP-9 levels were measured at baseline and Day 14 using ELISA.

  4. Change in serum superoxide dismutase (SOD; U/mL) from baseline to Day 14

    Time frame: Baseline, Day 14

    Serum SOD levels were measured at baseline and Day 14 using ELISA.

  5. Change in serum malondialdehyde (MDA; nmol/mL) from baseline to Day 14

    Time frame: Baseline, Day 14

    Serum MDA levels were measured at baseline and Day 14 using ELISA.

  6. Change in serum malondialdehyde (HO-1 (ng/mL)) from baseline to Day 14

    Time frame: Baseline, Day 14

    Serum HO-1 levels were measured at baseline and Day 14 using ELISA.

  7. Change in serum malondialdehyde (Keap1 (ng/mL)) from baseline to Day 14

    Time frame: Baseline, Day 14

    Serum Keap1 levels were measured at baseline and Day 14 using ELISA.

  8. Change in serum superoxide dismutase (NQO1 (ng/mL)) from baseline to Day 14

    Time frame: Baseline, Day 14

    Serum NQO1 levels were measured at baseline and Day 14 using ELISA.

  9. Change in serum malondialdehyde (Nrf2 (ng/mL)) from baseline to Day 14

    Time frame: Baseline, Day 14

    Serum Nrf2 levels were measured at baseline and Day 14 using ELISA.

  10. Serum metabolomic profile changes from baseline to Day 14

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Liaoning University of Traditional Chinese Medicine

Other

Registry information

Official study title

Buyang Huanwu Decoction Combined With Wuling Powder as Adjunctive Therapy for Acute Ischemic Stroke: A Randomized, Assessor-Blinded, Controlled Clinical Study

Acronym: BYHW-WL

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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