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NCT Number: NCT07139639

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

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.

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Key information

Conditions

Diabetic Lower Extremity Arterial Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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

Treatment and study plan

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

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

Primary outcomes

  1. Ulcer Recurrence Rate

    Time frame: Measured at 6 months post-intervention

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

Secondary outcomes

  1. Ulcer Recurrence Rate

    Time frame: Ulcer recurrence rates at 3, 9, and 12 months post-intervention

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

  2. Calculation of ulcer recurrence episodes

    Time frame: Assessed at 6 months post-intervention

    Recurrence is counted based on the timing of occurrence. Ulcers appearing concurrently at distinct anatomical sites are counted as one episode; those occurring at different time points are counted as multiple episodes.

  3. Ankle-Brachial Index

    Time frame: 6 and 12 months after intervention

  4. TCM Syndrome Score

    Time frame: at 3 and 6 months post-intervention

    TCM Syndrome Scoring Scale Description

    This scale quantifies six core manifestations of Qi Stagnation and Blood Stasis Syndrome in diabetic lower extremity arterial disease, using a four-tier scoring system (0/2/4/6 points):

    Limb coldness: Asymptomatic (0 pts); Occasional, self-relieved (2 pts); Persistent, relieved by warmth (4 pts); Persistent, unrelieved by warmth (6 pts)

    Limb pain: None (0 pts); Mild (2 pts); Moderate (4 pts); Severe (sleep-disturbing) (6 pts)

    Chest/abdominal distension: Absent (0 pts); Occasional mild (2 pts); Frequent moderate (4 pts); Frequent severe (6 pts)

    Skin temperature: Normal (0 pts); Slightly decreased (2 pts); Significantly decreased (4 pts); Cold (6 pts)

    Intermittent claudication: Absent (0 pts); Distance >500 meters (2 pts); 200-500 meters (4 pts); ≤200 meters (6 pts)

    Foot coloration: Normal (0 pts); Dark red (2 pts); Pale/purplish-dark (4 pts); Cyanosis/ecchymosis (6 pts)

  5. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)、All-Cause Mortality

    Time frame: 3, 6, 9, and 12 months after intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Yannan Wang

CONTACT

[email protected]

+86 13791130209

Sponsors and collaborators

Lead sponsor

Zheng Liu

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.