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.
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
Pure pressure ulcers
Pure neuropathic ulcers
Acute coronary syndrome within 3 months
Severe hepatic impairment (AST or ALT >1.5×ULN)
Parallel
Guanxinning Tablets
DrugGuanxinning 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
DrugMatching 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
Ulcer Recurrence Rate
Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100%
Ulcer Recurrence Rate
Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100%
Calculation of ulcer recurrence episodes
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.
Ankle-Brachial Index
TCM Syndrome Score
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)
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Zheng Liu
Lead sponsor
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Sponsor institution
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
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