Evidence-Based Evaluation of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease

Zheng Liu

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Diabetic Lower Extremity Arterial Disease

Treatments: Drug: Matching Placebo for Guanxinning; Drug: Guanxinning Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT07139639

2025-035-03-KY

2024ZD0532600, 2024ZD0532603 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: 18 to 80 years old (inclusive)

2. Diagnosis: Confirmed type 1 or type 2 diabetes mellitus

3. Meeting diagnostic criteria for diabetic lower extremity arterial disease (DLEAD)

4. TCM Syndrome: Qualified for Qi Stagnation and Blood Stasis syndrome pattern

5. Glycemic Control:

   • HbA1c ≤9% or Fasting plasma glucose ≤10 mmol/L

6. 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.

7. Consent: Voluntarily signed informed consent form

Exclusion criteria

• (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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 2 patient groups, including a placebo group

Experimental Arm

Experimental group

Description:

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

Treatment:

Drug: Guanxinning Tablets

Placebo Arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Matching Placebo for Guanxinning