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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of new-onset ischemic rest pain or foot ulcer at 12 months of treatment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard Therapy and Hua Yu Wan Capsule
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.
干预措施: Hua Yu Wan Capsule (Drug)
Standard Therapy and Hua Yu Wan Capsule
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.
干预措施: Aspirin (Drug)
Standard Therapy Alone
- 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.
干预措施: Aspirin (Drug)
结局指标
主要结局
Incidence of new-onset ischemic rest pain or foot ulcer at 12 months of treatment.
时间窗: 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.
次要结局
- Number of participants with investigator-confirmed new-onset ischemic rest pain or clinically confirmed ischemic foot ulcer at 12 months(From enrollment to the end of treatment at 12 months)
- Number of participants with major adverse cardiovascular and cerebrovascular events (MACCE)(From enrollment to the end of treatment at 12 months)
- Number of participants hospitalized during the study(From enrollment to the end of treatment at 12 months)
- Number of participants who die during the study(From enrollment to the end of treatment at 12 months)
- Change in ankle-brachial index（ABI） from baseline(reported at Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18)
- Change in toe-brachial index (TBI) from baseline(reported at Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18)
- Change in intermittent claudication distance from baseline(Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18)
- Rate of clinically driven lower-extremity arterial revascularization after treatment(From enrollment to the end of treatment at 12 months)
- Change in Vascular Quality of Life Questionnaire-6 score from baseline(From enrollment to the end of treatment at 12 months)
- Change in Traditional Chinese Medicine syndrome score from baseline(From enrollment to the end of treatment at 12 months)