Peripheral Arterial DiseasePhase 3NCT07658807
Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease
A Phase 3 study testing Hua Yu Wan Capsule and Aspirin in people with Peripheral Arterial Disease and Diabetic Angiopathies, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if adding a Traditional Chinese Medicine formula, Bu Yang Huanwu Decoction (specifically the capsule form called Hua Yu Wan Capsule), to standard treatment can help prevent leg pain at rest or foot ulcers in people with diabetic lower extremity vascular disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral Arterial Disease, Diabetic Angiopathies, Arterial Occlusive Diseases
- What is being tested?
- Hua Yu Wan Capsule and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years (inclusive), male or female.
- Diagnosed with diabetes mellitus according to the Chinese Diabetes Society (2024) Guidelines.
- Glycated hemoglobin (HbA1c) < 12%, with recent fasting blood glucose < 7.0 mmol/L OR postprandial blood glucose < 10.0 mmol/L, and triglycerides < 1.7 mmol/L.
- Diagnosed with LEAD, meeting the following criteria:
- Rutherford Classification 2, 3, or 4.
- Resting ABI ≤ 0.90, OR for patients with exertional symptoms and resting ABI > 0.90, a post-exercise treadmill test showing an ABI decrease of ≥15%.
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- Evidence of lower limb arterial stenosis or occlusion confirmed by duplex ultrasound, CTA, MRA, or DSA.
- TCM Pattern Diagnosis: Must conform to the TCM syndrome of Qi Deficiency and Blood Stasis, as defined by the study's TCM diagnostic criteria (referencing "Practical Diagnostic Criteria for Blood Stasis Syndrome" and "Integrated Chinese and Western Medicine Peripheral Vascular Disease"):
- Main Symptom: Lower limb weakness, or feeling of heaviness/discomfort after prolonged walking.
- Secondary Symptoms: Shortness of breath/lassitude in speaking; dry mouth with desire to drink; scaly skin.
- Tongue \& Pulse: Tongue with teeth marks, pale-purple with petechiae/ecchymosis; thin and choppy pulse.
- (Diagnosis confirmed by meeting 1 main symptom OR 2 secondary symptoms, assessed by a qualified TCM practitioner.)
- Voluntarily signs the Informed Consent Form (ICF) and is willing and able to comply with all study procedures and visits.
Who cannot join
- Known bleeding disorders or history of intracranial hemorrhage.
- Current use of anticoagulants (e.g., warfarin, dabigatran, factor Xa inhibitors).
- Presence of active infection.
- Severe cardiac abnormalities on resting ECG (e.g., heart failure, ventricular tachycardia, ventricular fibrillation, multifocal ventricular contractions, prolonged corrected QT interval).
- History of acute coronary syndrome ≤ 12 months requiring dual antiplatelet therapy.
- Chronic liver disease (Child-Turcote-Pugh score ≥5) or chronic kidney disease stages 4-5 (eGFR < 30 mL/min/1.73m²).
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- History of malignancy (except cured basal cell carcinoma).
- Moderate to severe anemia, polycythemia vera, or any hyperviscosity syndrome.
- Planned lower limb revascularization or amputation.
- Concurrent or planned use of medicinal products containing Veratrum species.
- Pregnant or lactating women, or women of childbearing potential not using highly effective contraception.
- Known allergy or hypersensitivity to any component of the study medication (Qilong Capsules, aspirin).
- Patients with psychiatric disorders or judged to be uncooperative.
- Currently participating in another drug clinical trial or using therapies with similar purported effects.
- Any other condition deemed by the investigator to make the participant unsuitable for the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital
Beijing
JIANMING GUO, M.D., +86 13146369562, guojianming@aliyun.com
About this study
Official title: Evidence-Based Evaluation and New Drug Translation Research of Early Intervention With the Classic Traditional Chinese Medicine Formula Bu Yang Huanwu Decoction for Preventing and Treating Diabetic Lower Extremity Vascular Disease
The goal of this clinical trial is to learn if adding a Traditional Chinese Medicine formula, Bu Yang Huanwu Decoction (specifically the capsule form called Hua Yu Wan Capsule), to standard treatment can help prevent leg pain at rest or foot ulcers in people with diabetic lower extremity vascular disease. The main questions it aims to answer are:
Does adding Hua Yu Wan Capsule to standard treatment lower the chance of developing leg pain at rest or foot ulcers after one year, compared to standard treatment alone?
Read more
Is the treatment combination safe for participants?
Researchers will compare two groups:
Group 1 (Experimental): Standard treatment (including aspirin, and medicines for blood sugar and cholesterol control) plus Hua Yu Wan Capsule.
Group 2 (Control): Standard treatment alone.
Participants in this study will:
Be adults aged 18 to 70 years with diabetes and early to moderate lower extremity vascular disease (confirmed by tests like the Ankle-Brachial Index or ABI).
Be randomly assigned to one of the two treatment groups.
Take their assigned treatment for 6 months.
Attend clinic visits at 1, 3 and 6 months during treatment, and again at 6 and 12 months after treatment ends for check-ups and tests.
- Being tested
- Hua Yu Wan Capsule, Aspirin
- Keywords
- Peripheral Arterial Disease, Ischemia, Medicine, Chinese Traditional, Randomized Controlled Trial
- Medical subject headings
- Peripheral Arterial Disease, Diabetic Angiopathies, Arterial Occlusive Diseases, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hua Yu Wan CapsuleDrug
A modern preparation of the classic Traditional Chinese Medicine formula Bu Yang Huanwu Decoction. Each capsule contains 0.2g of the herbal extract.
Dosage and Route: 2 capsules, taken orally three times daily.
AspirinDrug
Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy and Hua Yu Wan Capsule | Experimental | 1． Standard Baseline Medication: Hua Yu Wan Capsule: 5g, taken orally two times daily. Treatment Duration: The combined regimen is administered continuously for 6 months (divided into four 6-week cycles).
2. Follow-up: After the 6-month treatment period, participants enter a 12-month follow-up phase for observational assessments without receiving the study drug. Receives: Drug: Hua Yu Wan Capsule; Drug: Aspirin |
| Standard Therapy Alone | Active comparator | 1. Standard Baseline Medication:
Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 6 months.
2. Follow-up: After the 6-month treatment period, participants enter a 12-month follow-up phase for observational assessments. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new-onset ischemic rest pain or foot ulcer at 12 months of treatment.
Ischemic Rest Pain: Persistent pain in the toes/forefoot at rest, typically nocturnal, worsened by elevation, relieved by dependency, often with pallor/coldness.
Foot Ulcer: Ischemic skin breakdown/tissue necrosis in pressure areas (toes, heel, sole), with well-defined edges, dry/necrotic base, poor perfusion, and absence of significant inflammation.
Assessment Method: Clinical evaluation by investigator at each scheduled visit. Confirmed by physical examination and documented photographically if applicable.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (10)
Number of participants with investigator-confirmed new-onset ischemic rest pain or clinically confirmed ischemic foot ulcer at 12 months
Composite primary outcome defined as the number of participants who develop either: (1) new-onset ischemic rest pain confirmed by investigator clinical assessment, or (2) ischemic foot ulcer confirmed by physical examination with photographic documentation when applicable, by Month 12.
Measured: From enrollment to the end of treatment at 12 months
Number of participants with major adverse cardiovascular and cerebrovascular events (MACCE)
MACCE is defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
Measured: From enrollment to the end of treatment at 12 months
Number of participants hospitalized during the study
Number of participants who require inpatient hospitalization for any cause during the study period, as confirmed by hospital admission records or investigator documentation. Repeated hospitalizations in the same participant will be counted once unless otherwise specified in the statistical analysis plan.
Measured: From enrollment to the end of treatment at 12 months
Number of participants who die during the study
Number of participants who die from any cause during the study period, as confirmed by medical records, death certificates, hospital documentation, or investigator follow-up. Each participant will be counted once.
Measured: From enrollment to the end of treatment at 12 months
Change in ankle-brachial index（ABI） from baseline
Change in ankle-brachial index from baseline: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period.
Measured: reported at Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Change in toe-brachial index (TBI) from baseline
Change in toe-brachial index from baseline: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period.
Measured: reported at Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Change in intermittent claudication distance from baseline
Change in intermittent claudication distance from baseline: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period.
Measured: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Rate of clinically driven lower-extremity arterial revascularization after treatment
Rate of clinically driven lower-extremity arterial revascularization after treatment, including endovascular or open surgical revascularization: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period.
Measured: From enrollment to the end of treatment at 12 months
Change in Vascular Quality of Life Questionnaire-6 score from baseline
Change in Vascular Quality of Life Questionnaire-6 score from baseline: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period.
Measured: From enrollment to the end of treatment at 12 months
Change in Traditional Chinese Medicine syndrome score from baseline
Change in Traditional Chinese Medicine syndrome score from baseline: Month 1, Month 3, and Month 6 during the treatment period; Month 6 and Month 12 during the follow-up period.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Dongzhimen Hospital, Beijing, Peking University Third Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658807
- Sponsor's protocol ID
- BYHWT-EDVD
- Status last verified
- Jun 2026
- First submitted
- 11 Feb 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Evaluation and New Drug Translation Research of Early Intervention With the Classic Traditional Chinese Medicine Formula Bu Yang Huanwu Decoction for Preventing and Treating Diabetic Lower Extremity Vascular Disease
- ClinicalTrials.gov ID
- NCT07658807
- Acronym / sponsor ID
- BYHWT-EDVD
- Keywords
- Peripheral Arterial Disease, Ischemia, Medicine, Chinese Traditional, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Dongzhimen Hospital, Beijing, Peking University Third Hospital
- Study start
- Jun 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 Jun 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.
The goal of this clinical trial is to learn if adding a Traditional Chinese Medicine formula, Bu Yang Huanwu Decoction (specifically the capsule form called Hua Yu Wan Capsule), to standard treatment can help prevent leg pain at rest or foot ulcers in people with diabetic lower extremity vascular disease. The main questions it aims to answer are:
Does adding Hua Yu Wan Capsule to standard treatment lower the chance of developing leg pain at rest or foot ulcers after one year, compared to standard treatment alone?
Is the treatment combination safe for participants?
Researchers will compare two groups:
Group 1 (Experimental): Standard treatment (including aspirin, and medicines for blood sugar and cholesterol control) plus Hua Yu Wan Capsule.
Group 2 (Control): Standard treatment alone.
Participants in this study will:
Be adults aged 18 to 70 years with diabetes and early to moderate lower extremity vascular disease (confirmed by tests like the Ankle-Brachial Index or ABI).
Be randomly assigned to one of the two treatment groups.
Take their assigned treatment for 6 months.
Attend clinic visits at 1, 3 and 6 months during treatment, and again at 6 and 12 months after treatment ends for check-ups and tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy and Hua Yu Wan Capsule | Experimental | Drug: Hua Yu Wan Capsule, Drug: Aspirin1． Standard Baseline Medication: Hua Yu Wan Capsule: 5g, taken orally two times daily. Treatment Duration: The combined regimen is administered continuously for 6 months (divided into four 6-week cycles). 2. Follow-up: After the 6-month treatment period, participants enter a 12-month follow-up phase for observational assessments without receiving the study drug. |
| Standard Therapy Alone | Active comparator | Drug: Aspirin1. Standard Baseline Medication: Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 6 months. 2. Follow-up: After the 6-month treatment period, participants enter a 12-month follow-up phase for observational assessments. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18 to 70 years (inclusive), male or female.
- Diagnosed with diabetes mellitus according to the Chinese Diabetes Society (2024) Guidelines.
- Glycated hemoglobin (HbA1c) < 12%, with recent fasting blood glucose < 7.0 mmol/L OR postprandial blood glucose < 10.0 mmol/L, and triglycerides < 1.7 mmol/L.
- Diagnosed with LEAD, meeting the following criteria:
- Rutherford Classification 2, 3, or 4.
Key exclusion criteria (15 listed)
- Known bleeding disorders or history of intracranial hemorrhage.
- Current use of anticoagulants (e.g., warfarin, dabigatran, factor Xa inhibitors).
- Presence of active infection.
- Severe cardiac abnormalities on resting ECG (e.g., heart failure, ventricular tachycardia, ventricular fibrillation, multifocal ventricular contractions, prolonged corrected QT interval).
- History of acute coronary syndrome ≤ 12 months requiring dual antiplatelet therapy.
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 |
|---|---|---|
| Hua Yu Wan CapsuleA modern preparation of the classic Traditional Chinese Medicine formula Bu Yang Huanwu Decoction. Each capsule contains 0.2g of the herbal extract. Dosage and Route: 2 capsules, taken orally three times daily. | Drug | Standard Therapy and Hua Yu Wan Capsule |
| AspirinAspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 12 months. | Drug | Standard Therapy Alone, Standard Therapy and Hua Yu Wan Capsule |
Primary outcome
Incidence of new-onset ischemic rest pain or foot ulcer at 12 months of treatment.
Time frame: From enrollment to the end of treatment at 12 months
Ischemic Rest Pain: Persistent pain in the toes/forefoot at rest, typically nocturnal, worsened by elevation, relieved by dependency, often with pallor/coldness. Foot Ulcer: Ischemic skin breakdown/tissue necrosis in pressure areas (toes, heel, sole), with well-defined edges, dry/necrotic base, poor perfusion, and absence of significant inflammation. Assessment Method: Clinical evaluation by investigator at each scheduled visit. Confirmed by physical examination and documented photographically if applicable.
10 secondary outcomes
Number of participants with investigator-confirmed new-onset ischemic rest pain or clinically confirmed ischemic foot ulcer at 12 months
Time frame: From enrollment to the end of treatment at 12 months
Number of participants with major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: From enrollment to the end of treatment at 12 months
Number of participants hospitalized during the study
Time frame: From enrollment to the end of treatment at 12 months
Number of participants who die during the study
Time frame: From enrollment to the end of treatment at 12 months
Change in ankle-brachial index（ABI） from baseline
Time frame: reported at Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Change in toe-brachial index (TBI) from baseline
Time frame: reported at Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Change in intermittent claudication distance from baseline
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Rate of clinically driven lower-extremity arterial revascularization after treatment
Time frame: From enrollment to the end of treatment at 12 months
Change in Vascular Quality of Life Questionnaire-6 score from baseline
Time frame: From enrollment to the end of treatment at 12 months
Change in Traditional Chinese Medicine syndrome score from baseline
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hua Yu Wan Capsule and Aspirin in people with Peripheral Arterial Disease and Diabetic Angiopathies, run by Xuanwu Hospital, Beijing 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 13 inclusion and 15 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: opening soon, as of the sponsor's last update on 22 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JIANMING GUO, M.D. (+86 13146369562, guojianming@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new-onset ischemic rest pain or foot ulcer at 12 months of treatment. (time frame: From enrollment to the end of treatment at 12 months). 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 22 Jun 2026.