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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Procedure: Standard Western Medical Treatment; Procedure: Standard Western Medical Treatment; Drug: Buyang Huanwu Decoction Combined With Wuling Powder; Other: Serum Sample Collection for Metabolomics Only

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110034
      • The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Standard Western Medical Treatment; Standard guideline-based medical care for acute ischemic stroke.; Procedure: Standard Western Medical Treatment; 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.	Procedure: Standard Western Medical Treatment; Standard guideline-based medical care for acute ischemic stroke.; Procedure: Standard Western Medical Treatment; Guideline-based acute ischemic stroke management.; Drug: Buyang Huanwu Decoction Combined With Wuling Powder; 14-day oral decoction, twice daily, composed of Astragali Radix, Angelicae Sinensis Radix, and other herbs as specified.
Sham Comparator: 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.	Other: Serum Sample Collection for Metabolomics Only; Blood samples collected for metabolomic profiling only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in National Institutes of Health Stroke Scale (NIHSS; 0-42) score from baseline to 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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale Score at 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	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	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	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	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	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	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	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	Serum Nrf2 levels were measured at baseline and Day 14 using ELISA.	Baseline, Day 14
Serum metabolomic profile changes from baseline to 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

Collaborators and Investigators

• Sponsor: Liaoning University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): April 20, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: June 28, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Acute Ischemic Stroke; Buyang Huanwu Decoction
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2023(XS)-001-02(FS); Ethics Committee (Other Identifier: LNU TCM Second Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No