Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease

Sponsor
Xuanwu Hospital, Beijing
Study ID
NCT07658807
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Arterial Occlusive Diseases
  • Diabetic Angiopathies
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Hua Yu Wan Capsule — DRUG
    A modern preparation of the classic Traditional Chinese Medicine formula Bu Yang Huanwu Decoction. Each capsule contains 0.2g of the herbal extract. Dosage and Route: 2 capsules, taken orally three times daily.
  • Aspirin — DRUG
    Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 12 months.

Study Details

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.

Key Dates

First listed
Jun 22, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Feb 29, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Standard Therapy and Hua Yu Wan Capsule
    1． Standard Baseline Medication: Hua Yu Wan Capsule: 5g, taken orally two times daily. Treatment Duration: The combined regimen is administered continuously for 6 months (divided into four 6-week cycles). 2\. Follow-up: After the 6-month treatment period, participants enter a 12-month follow-up phase for observational assessments without receiving the study drug.
  • Active Comparator: Standard Therapy Alone
    1. Standard Baseline Medication: Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 6 months. 2. Follow-up: After the 6-month treatment period, participants enter a 12-month follow-up phase for observational assessments.

Primary Outcome Measure

Incidence of new-onset ischemic rest pain or foot ulcer at 12 months of treatment. [ Time Frame: From enrollment to the end of treatment at 12 months ]

Central Contacts

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