Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease (NCT07658807) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease
China300 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 to 70 years (inclusive), male or female.
. Diagnosed with diabetes mellitus according to the Chinese Diabetes Society (2024) Guidelines.
. Glycated hemoglobin (HbA1c) \< 12%, with recent fasting blood glucose \< 7.0 mmol/L OR postprandial blood glucose \< 10.0 mmol/L, and triglycerides \< 1.7 mmol/L.
. Diagnosed with LEAD, meeting the following criteria:
. TCM Pattern Diagnosis: Must conform to the TCM syndrome of Qi Deficiency and Blood Stasis, as defined by the study's TCM diagnostic criteria (referencing "Practical Diagnostic Criteria for Blood Stasis Syndrome" and "Integrated Chinese and Western Medicine Peripheral Vascular Disease"):
. Voluntarily signs the Informed Consent Form (ICF) and is willing and able to comply with all study procedures and visits.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of new-onset ischemic rest pain or foot ulcer at 12 months of treatment.
Timeframe: From enrollment to the end of treatment at 12 months