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

NCT ID: NCT07139639

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2028-12-01

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 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.

Conditions

Diabetic Lower Extremity Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Guanxinning Tablets

Intervention Type: DRUG

Guanxinning Tablets

• Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd.
• NMPA Approval No. Z20150028
• Administration: 4 tablets orally, three times daily for 6 months

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

Group Type: PLACEBO_COMPARATOR

Matching Placebo for Guanxinning

Intervention Type: DRUG

Matching Placebo for Guanxinning Tablets

• Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd.
• Drug Product Certificate of Analysis Approval No.YF-R-C037A-2024104-A
• Administration: 4 tablets orally, three times daily for 6 months

Interventions

Guanxinning Tablets

Guanxinning Tablets

• Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd.
• NMPA Approval No. Z20150028
• Administration: 4 tablets orally, three times daily for 6 months

Intervention Type: DRUG

Matching Placebo for Guanxinning

Matching Placebo for Guanxinning Tablets

• Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd.
• Drug Product Certificate of Analysis Approval No.YF-R-C037A-2024104-A
• Administration: 4 tablets orally, three times daily for 6 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Zheng Liu

OTHER

Sponsor Role: lead

Responsible Party

Zheng Liu

MD-PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Yannan Wang

Role: CONTACT

cweiyue@163.com

+86 13791130209

Other Identifiers

2024ZD0532600, 2024ZD0532603

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025-035-03-KY

Identifier Type: -

Identifier Source: org_study_id