Evidence-Based Evaluation and New Drug Development of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 主要终点
- Ulcer Recurrence Rate
研究概览
简要总结
Taking the approach of promoting qi circulation and activating blood as the entry point, this study targets lower extremity arterial disease（LEAD） patients with TCM syndrome pattern of blood stasis due to qi stagnation. Using Guanxinning Tablets (a herbal formula with qi-moving and blood-activating properties) as the investigational medication, we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the classic herb pair (Chuanxiong Rhizoma-Salviae Miltiorrhizae) in preventing LEAD ulcer recurrence. This research aims to accumulate evidence-based medical data supporting new drug development.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 80 years old (inclusive)
- •Diagnosis: Confirmed type 1 or type 2 diabetes mellitus
- •Meeting diagnostic criteria for diabetic lower extremity arterial disease (DLEAD)
- •TCM Syndrome: Qualified for Qi Stagnation and Blood Stasis syndrome pattern
- •Glycemic Control:
- •HbA1c ≤9% or Fasting plasma glucose ≤10 mmol/L
- •Ulcer History:
- •Documented history of diabetic lower extremity arterial disease (DLEAD)-related ulcers, with confirmed healing (wound re-epithelialization without signs of redness, purulent discharge, or infection) 2-8 weeks prior to enrollment.
- •Consent: Voluntarily signed informed consent form
排除标准
- •(1) Ulcer Etiology Exclusion:
- •Pure pressure ulcers
- •Pure neuropathic ulcers
- •Immune-mediated ulcers (e.g., vasculitic ulcers caused by lupus, Behcet's disease, rheumatoid arthritis) (2) Recent Cardiovascular Events:
- •Acute coronary syndrome within 3 months
- •Hemorrhagic stroke within 3 months (3) Organ Dysfunction:
- •Severe hepatic impairment (AST or ALT >1.5×ULN)
- •Chronic kidney disease stage 4-5 (eGFR <30 mL/min/1.73m²) (4) Recent Major Bleeding:
- •Gastrointestinal hemorrhage within 1 month (5) Concurrent TCM Therapy:
- •Use of blood-activating/stasis-resolving TCM preparations for DLEAD within 1 week (6) Herbal Contraindication:
- •Concurrent or planned use of *Veratrum*-containing preparations (7) Malignancy:
- •Active cancer progression (8) Reproductive Status:
- •Pregnant or lactating women (9) Allergy History:
- •Known hypersensitivity to *Ligusticum chuanxiong* or *Salvia miltiorrhiza* (10) Cognitive/Language Barriers:
- •Psychiatric disorders
- •Intellectual/language impairment affecting scale completion
- •Unwillingness to cooperate (11) Life Expectancy:
- •<1 year (12) Clinical Trial Participation:
- •Enrollment in other drug trials within 1 month (13) Investigator's Discretion:
- •Other conditions deemed unsuitable for participation
研究组 & 干预措施
Experimental Arm
Background Therapy Strict dietary control
Standardized medication Administered according to glycemic, lipid, and blood pressure treatment guidelines
Individualized antithrombotic regimen:
- First-line: Aspirin 100mg/d
- Alternative: Clopidogrel 75mg/d or other antithrombotic agents if aspirin allergy Note: Specific interventions adjusted based on actual clinical conditions Experimental Arm Background therapy + Guanxinning Tablets
干预措施: Guanxinning Tablets (Drug)
Placebo Arm
ackground Therapy Strict dietary control
Standardized medication Administered according to glycemic, lipid, and blood pressure treatment guidelines
Individualized antithrombotic regimen:
- First-line: Aspirin 100mg/d
- Alternative: Clopidogrel 75mg/d or other antithrombotic agents if aspirin allergy Note: Specific interventions adjusted based on actual clinical conditions Placebo Arm Background therapy + Matching Placebo for Guanxinning Tablets
干预措施: Matching Placebo for Guanxinning (Drug)
结局指标
主要结局
Ulcer Recurrence Rate
时间窗: Measured at 6 months post-intervention
Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100%
次要结局
- Ulcer Recurrence Rate(Ulcer recurrence rates at 3, 9, and 12 months post-intervention)
- Calculation of ulcer recurrence episodes(Assessed at 6 months post-intervention)
- Ankle-Brachial Index(6 and 12 months after intervention)
- TCM Syndrome Score(at 3 and 6 months post-intervention)
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)、All-Cause Mortality(3, 6, 9, and 12 months after intervention)
研究者
Zheng Liu
MD-PhD
Affiliated Hospital of Shandong University of Traditional Chinese Medicine