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)
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