Buyang Huanwu Decoction With Wuling Powder for Acute Ischemic Stroke

NCT07687043 | Completed DMC

• 2 other identifiers: 2023(XS)-001-02(FS)Ethics Committee
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Buyang Huanwu Decoction; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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

Study Arms (3)

Standard Western Medical Treatment

ACTIVE COMPARATOR

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

Buyang Huanwu Decoction Combined With Wuling Powder Plus Standard Western Medical Treatment

EXPERIMENTAL

Participants received Buyang Huanwu Decoction combined with Wuling Powder in addition to standard Western medical treatment for 14 days.

Drug: Buyang Huanwu Decoction Combined With Wuling Powder; Procedure: Standard Western Medical Treatment

Non-Stroke Metabolomic Reference Group

SHAM COMPARATOR

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

Interventions

Standard Western Medical Treatment PROCEDURE

Standard guideline-based medical care for acute ischemic stroke.

Standard Western Medical Treatment

Serum Sample Collection for Metabolomics Only OTHER

Blood samples collected for metabolomic profiling only.

Non-Stroke Metabolomic Reference Group

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.

Buyang Huanwu Decoction Combined With Wuling Powder Plus Standard Western Medical Treatment

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaoning University of Traditional Chinese Medicine: lead

Study Sites (1)

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, 110034, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 7, 2026
• Study Start: March 20, 2023
• Primary Completion: April 20, 2025
• Study Completion: June 30, 2025
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)