drugset / Trial / NCT07139639
Evidence-Based Evaluation of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease
Phase 0
Not yet recruiting
350 enrolled
Zheng Liu
Beijing Shijitan Hospital, Capital Medical University · collabDongzhimen Hospital, Beijing · collabLiyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology · collabPeking University Third Hospital · collabThe First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine · collabXuanwu Hospital, Beijing · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2025-11-01
- Primary completion
- 2027-11-01
- Completion
- 2028-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guanxinning Tablets | Traditional medicine (herbal / TCM) | 4 unknown | Oral |