A Phase 3 interventional study of Hua Yu Wan Capsule and Aspirin in Peripheral Arterial Disease, Diabetic Angiopathies and Arterial Occlusive Diseases, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Xuanwu Hospital, Beijing · Phase 3, Interventional, and Prevention
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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 300 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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%.
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.)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Hua Yu Wan Capsule · Drug: Aspirin
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.
Drug: Aspirin
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.
Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 12 months.
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.
Time frame: From enrollment to the end of treatment at 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 months
Number of participants with clinically significant bleeding events
Number of participants with bleeding events during the study. Unit of Measure: Participants
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of participants with clinically significant abnormal physical examination findings
Number of participants with clinically significant abnormal findings on physical examination.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of participants with clinically significant abnormal hematology test results
Number of participants with clinically significant abnormalities in hematology parameters, including white blood cell count, red blood cell count, hemoglobin, and platelet count.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of participants with clinically significant abnormal urinalysis results
Number of participants with clinically significant abnormalities in urinalysis parameters, including urine white blood cells, urine red blood cells, urine glucose, and urine protein.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of participants with clinically significant abnormal liver function test results
Number of participants with clinically significant abnormalities in liver function parameters, including alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, and gamma-glutamyl transferase.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of participants with clinically significant abnormal renal function test results
Number of participants with clinically significant abnormalities in renal function parameters, including blood urea nitrogen or urea, and serum creatinine.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of participants with clinically significant abnormal coagulation test results
Number of participants with clinically significant abnormalities in coagulation function parameters, including thrombin time, prothrombin time, activated partial thromboplastin time, international normalized ratio, and fibrinogen.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Change in Body Temperature From Baseline
Change in body temperature from baseline at each scheduled assessment. Unit of Measure: Degrees Celsius
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Change in Pulse Rate From Baseline
Change in pulse rate from baseline at each scheduled assessment. Unit of Measure: Beats per minute
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Change in Respiratory Rate From Baseline
Change in respiratory rate from baseline at each scheduled assessment. Unit of Measure: Breaths per minute
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Change in Systolic Blood Pressure From Baseline
Change in systolic blood pressure from baseline at each scheduled assessment. Unit of Measure: mmHg
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Change in Diastolic Blood Pressure From Baseline
Change in diastolic blood pressure from baseline at each scheduled assessment. Unit of Measure: mmHg
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of participants with clinically significant abnormal 12-lead electrocardiogram findings
Measure Description: Number of participants with clinically significant abnormal findings on 12-lead electrocardiogram, as assessed by the investigator. Unit of Measure: Participants
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of participants with positive pregnancy test results
Number of female participants of childbearing potential with positive pregnancy test results during the study.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of Participants With Allergic Reactions
Number of participants with allergic reactions during the study.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of Participants With Gastrointestinal Adverse Reactions
Number of participants with gastrointestinal adverse reactions during the study.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Number of Participants With Nervous System Adverse Reactions
Number of participants with nervous system adverse reactions during the study.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18
Plan to share: Undecided
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