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.

NCT Number	NCT07139639
Lead Sponsor	Zheng Liu Collaborators: Beijing Shijitan Hospital, Capital Medical University, Peking University Third Hospital, Dongzhimen Hospital, Beijing, Xuanwu Hospital, Beijing, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Conditions	Diabetic Lower Extremity Arterial Disease
Enrollment	350 participants
Start Date	2025-11-01
Primary Completion	2027-11-01 (estimated)
Study Completion	2028-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-08-24