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Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease

NCT07658807 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-06-22

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease
  • Diabetic Angiopathies
  • Arterial Occlusive Diseases

Interventions

DRUG

Hua Yu Wan Capsule

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.

DRUG

Aspirin

Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 12 months.

Sponsors & Collaborators

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    collaborator OTHER

  • Dongzhimen Hospital, Beijing

    collaborator OTHER

  • Peking University Third Hospital

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-02-29
Completion
2029-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658807 on ClinicalTrials.gov