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NCT Number: NCT07658807

Evaluating Bu Yang Huanwu Decoction For Early Diabetic 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?

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

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.

Exclusion criteria

  • 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).
  • 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.

Treatment and study plan

Hua Yu Wan Capsule

Drug

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

Drug

Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 12 months.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Number of participants with major adverse cardiovascular and cerebrovascular events (MACCE)

    Time frame: From enrollment to the end of treatment at 12 months

    MACCE is defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

  3. Number of participants hospitalized during the study

    Time frame: From enrollment to the end of treatment at 12 months

    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.

  4. Number of participants who die during the study

    Time frame: From enrollment to the end of treatment at 12 months

    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.

  5. 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 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.

  6. 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 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.

  7. Change in intermittent claudication distance from baseline

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    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.

  8. Rate of clinically driven lower-extremity arterial revascularization after treatment

    Time frame: From enrollment to the end of treatment at 12 months

    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.

  9. 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 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.

  10. Change in Traditional Chinese Medicine syndrome score from baseline

    Time frame: From enrollment to the end of treatment at 12 months

    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.

Other outcomes

  1. Number of participants with clinically significant bleeding events

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Number of participants with bleeding events during the study. Unit of Measure: Participants

  2. Number of participants with clinically significant abnormal physical examination findings

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Number of participants with clinically significant abnormal findings on physical examination.

  3. Number of participants with clinically significant abnormal hematology test results

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Number of participants with clinically significant abnormalities in hematology parameters, including white blood cell count, red blood cell count, hemoglobin, and platelet count.

  4. Number of participants with clinically significant abnormal urinalysis results

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Number of participants with clinically significant abnormalities in urinalysis parameters, including urine white blood cells, urine red blood cells, urine glucose, and urine protein.

  5. Number of participants with clinically significant abnormal liver function test results

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Number of participants with clinically significant abnormalities in liver function parameters, including alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, and gamma-glutamyl transferase.

  6. Number of participants with clinically significant abnormal renal function test results

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Number of participants with clinically significant abnormalities in renal function parameters, including blood urea nitrogen or urea, and serum creatinine.

  7. Number of participants with clinically significant abnormal coagulation test results

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    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.

  8. Change in Body Temperature From Baseline

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Change in body temperature from baseline at each scheduled assessment. Unit of Measure: Degrees Celsius

  9. Change in Pulse Rate From Baseline

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Change in pulse rate from baseline at each scheduled assessment. Unit of Measure: Beats per minute

  10. Change in Respiratory Rate From Baseline

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Change in respiratory rate from baseline at each scheduled assessment. Unit of Measure: Breaths per minute

  11. Change in Systolic Blood Pressure From Baseline

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Change in systolic blood pressure from baseline at each scheduled assessment. Unit of Measure: mmHg

  12. Change in Diastolic Blood Pressure From Baseline

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Change in diastolic blood pressure from baseline at each scheduled assessment. Unit of Measure: mmHg

  13. Number of participants with clinically significant abnormal 12-lead electrocardiogram findings

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Measure Description: Number of participants with clinically significant abnormal findings on 12-lead electrocardiogram, as assessed by the investigator.

    Unit of Measure: Participants

  14. Number of participants with positive pregnancy test results

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Number of female participants of childbearing potential with positive pregnancy test results during the study.

  15. Number of Participants With Allergic Reactions

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Number of participants with allergic reactions during the study.

  16. Number of Participants With Gastrointestinal Adverse Reactions

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Number of participants with gastrointestinal adverse reactions during the study.

  17. Number of Participants With Nervous System Adverse Reactions

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18

    Number of participants with nervous system adverse reactions during the study.

Study contacts

Contact information is provided by the study sponsor or research team.

JIANMING GUO, M.D.

CONTACT

[email protected]

+86 13146369562

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • Dongzhimen Hospital, Beijing
  • Peking University Third Hospital

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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