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

NCT07139639 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: 2025-035-03-KY2024ZD0532600, 2024ZD0532603
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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

Keywords

Recurrence of ulcer; Diabetic Lower extremity arterial disease; Interventional Study; Prevention; Guanxinning Tablets; Salviae Miltiorrhizae; Chuanxiong Rhizoma

Outcome Measures

Primary Outcomes (1)

• Ulcer Recurrence Rate

  Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100%

  Measured at 6 months post-intervention

Secondary Outcomes (5)

• 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

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Drug: Guanxinning Tablets

Placebo Arm

PLACEBO COMPARATOR

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

Drug: Matching Placebo for Guanxinning

Interventions

Guanxinning Tablets DRUG

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

Experimental Arm

Matching Placebo for Guanxinning 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

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zheng Liu: lead
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Peking University Third Hospital: collaborator
• Dongzhimen Hospital, Beijing: collaborator
• Xuanwu Hospital, Beijing: collaborator
• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: collaborator
• Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology: collaborator

Central Study Contacts

Yannan Wang

CONTACT

+86 13791130209; cweiyue@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD-PhD

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share