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Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
The goal of this clinical trial is to learn if adding a Traditional Chinese Medicine formula, Bu Yang Huanwu Decoction (specifically the capsule form called Hua Yu Wan Capsule), to standard treatment can help prevent leg pain at rest or foot ulcers in people with diabetic lower extremity vascular disease. The main questions it aims to answer are: Does adding Hua Yu Wan Capsule to standard treatment lower the chance of developing leg pain at rest or foot ulcers after one year, compared to standard treatment alone? Is the treatment combination safe for participants? Researchers will compare two groups: Group 1 (Experimental): Standard treatment (including aspirin, and medicines for blood sugar and cholesterol control) plus Hua Yu Wan Capsule. Group 2 (Control): Standard treatment alone. Participants in this study will: Be adults aged 18 to 70 years with diabetes and early to moderate lower extremity vascular disease (confirmed by tests like the Ankle-Brachial Index or ABI). Be randomly assigned to one of the two treatment groups. Take their assigned treatment for 6 months. Attend clinic visits at 1, 3 and 6 months during treatment, and again at 6 and 12 months after treatment ends for check-ups and tests.
Trial Details
NCT Number NCT07658807
Lead Sponsor Xuanwu Hospital, Beijing
Collaborators: Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Dongzhimen Hospital, Beijing, Peking University Third Hospital
Conditions
(from sponsor)
Peripheral Arterial Disease, Diabetic Angiopathies, Arterial Occlusive Diseases
Related terms Arterial Occlusive Diseases, Diabetic Angiopathies, Ischemia, Peripheral Arterial Disease
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov