Acute Ischemic StrokeBYHW-WLNCT07687043
Buyang Huanwu Decoction With Wuling Powder for Acute Ischemic Stroke
A study testing Standard Western Medical Treatment, Serum Sample Collection for Metabolomics Only and Buyang Huanwu Decoction Combined With Wuling Powder in people with Acute Ischemic Stroke, run by Liaoning University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Standard Western Medical Treatment, Serum Sample Collection for Metabolomics Only and Buyang Huanwu Decoction Combined With Wuling Powder
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, 110034
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Standard Western Medical Treatment, Serum Sample Collection for Metabolomics Only, Buyang Huanwu Decoction Combined With Wuling Powder
- Keywords
- Acute Ischemic Stroke, Buyang Huanwu Decoction, Traditional Chinese Medicine
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Western Medical TreatmentProcedure or surgery
Standard guideline-based medical care for acute ischemic stroke.
Serum Sample Collection for Metabolomics OnlyOther
Blood samples collected for metabolomic profiling only.
Buyang Huanwu Decoction Combined With Wuling PowderDrug
14-day oral decoction, twice daily, composed of Astragali Radix, Angelicae Sinensis Radix, and other herbs as specified.
Standard Western Medical TreatmentProcedure or surgery
Guideline-based acute ischemic stroke management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Serum Sample Collection for Metabolomics Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Baseline and Day 14
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start20 Mar 2023
- Primary completion20 Apr 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaoning University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changchuan Bai, Liaoning University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687043
- Sponsor's protocol ID
- 2023(XS)-001-02(FS)
- Other IDs
- Ethics Committee
- Acronym
- BYHW-WL
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buyang Huanwu Decoction Combined With Wuling Powder as Adjunctive Therapy for Acute Ischemic Stroke: A Randomized, Assessor-Blinded, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07687043
- Acronym / sponsor ID
- BYHW-WL / 2023(XS)-001-02(FS)
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Buyang Huanwu Decoction, Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Liaoning University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Western Medical Treatment | Active comparator | Procedure: Standard Western Medical TreatmentParticipants 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. |
| Buyang Huanwu Decoction Combined With Wuling Powder Plus Standard Western Medical Treatment | Experimental | Drug: Buyang Huanwu Decoction Combined With Wuling Powder, Procedure: Standard Western Medical TreatmentParticipants received Buyang Huanwu Decoction combined with Wuling Powder in addition to standard Western medical treatment for 14 days. |
| Non-Stroke Metabolomic Reference Group | Sham comparator | Other: Serum Sample Collection for Metabolomics OnlyParticipants provided serum samples only for metabolomic comparison and did not receive any therapeutic intervention. This group was not part of the randomized treatment allocation. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Western Medical TreatmentStandard guideline-based medical care for acute ischemic stroke. | Procedure or surgery | Standard Western Medical Treatment |
| Serum Sample Collection for Metabolomics OnlyBlood samples collected for metabolomic profiling only. | Other | Non-Stroke Metabolomic Reference Group |
| Buyang Huanwu Decoction Combined With Wuling Powder14-day oral decoction, twice daily, composed of Astragali Radix, Angelicae Sinensis Radix, and other herbs as specified. | Drug | Buyang Huanwu Decoction Combined With Wuling Powder Plus Standard Western Medical Treatment |
| Standard Western Medical TreatmentGuideline-based acute ischemic stroke management. | Procedure or surgery | Buyang Huanwu Decoction Combined With Wuling Powder Plus Standard Western Medical Treatment |
Primary outcome
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
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.
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.
10 secondary outcomes
Modified Rankin Scale Score at 90 Days After Stroke Onset
Time frame: 90 days after stroke onset
Incidence of Adverse Events During the Treatment Period
Time frame: Baseline to Day 14
Change in serum MMP-9 (ng/mL) from baseline to Day 14
Time frame: Baseline, Day 14
Change in serum superoxide dismutase (SOD; U/mL) from baseline to Day 14
Time frame: Baseline, Day 14
Change in serum malondialdehyde (MDA; nmol/mL) from baseline to Day 14
Time frame: Baseline, Day 14
Change in serum malondialdehyde (HO-1 (ng/mL)) from baseline to Day 14
Time frame: Baseline, Day 14
Change in serum malondialdehyde (Keap1 (ng/mL)) from baseline to Day 14
Time frame: Baseline, Day 14
Change in serum superoxide dismutase (NQO1 (ng/mL)) from baseline to Day 14
Time frame: Baseline, Day 14
Change in serum malondialdehyde (Nrf2 (ng/mL)) from baseline to Day 14
Time frame: Baseline, Day 14
Serum metabolomic profile changes from baseline to Day 14
Time frame: Baseline, Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Western Medical Treatment, Serum Sample Collection for Metabolomics Only and Buyang Huanwu Decoction Combined With Wuling Powder in people with Acute Ischemic Stroke, run by Liaoning University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in National Institutes of Health Stroke Scale (NIHSS; 0-42) score from baseline to Day 14 (time frame: Baseline and Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.