Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease

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

Overview

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.

Interventions

• Drug Hua Yu Wan Capsule
  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.
• Drug Aspirin
  Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 12 months.

Primary outcome measures

• 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]

Secondary outcome measures (10)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

China · 1 center

• Xuanwu Hospital — Beijing

Identifiers

NCT: NCT07658807 · BYHWT-EDVD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗