Status:
NOT_YET_RECRUITING
Evidence-Based Evaluation of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease
Lead Sponsor:
Zheng Liu
Collaborating Sponsors:
Beijing Shijitan Hospital, Capital Medical University
Peking University Third Hospital
Conditions:
Diabetic Lower Extremity Arterial Disease
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
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 du...
Eligibility Criteria
Inclusion
- 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
Exclusion
- (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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT07139639
Start Date
November 1 2025
End Date
December 1 2028
Last Update
August 24 2025
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