Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Voluntarily signs the Informed Consent Form (ICF) and is willing and able to comply with all study procedures and visits.
Disqualifiers
Known bleeding disorders or history of intracranial hemorrhage.
Current use of anticoagulants (e.g., warfarin, dabigatran, factor Xa inhibitors).
Presence of active infection.
Severe cardiac abnormalities on resting ECG (e.g., heart failure, ventricular tachycardia, ventricular fibrillation, multifocal ventricular contractions, prolonged corrected QT interval).
Trial design
Design model
Parallel
Treatments tested in this trial
Hua Yu Wan Capsule
DrugA 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
DrugAspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 12 months.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Standard Therapy and Hua Yu Wan CapsuleExperimental treatment 2 interventions
Group B: Standard Therapy AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of new-onset ischemic rest pain or foot ulcer at 12 months of treatment.
Ischemic Rest Pain: Persistent pain in the toes/forefoot at rest, typically nocturnal, worsened by elevation, relieved by dependency, often with pallor/coldness. Foot Ulcer: Ischemic skin breakdown/tissue necrosis in pressure areas (toes, heel, sole), with well-defined edges, dry/necrotic base, poor perfusion, and absence of significant inflammation. Assessment Method: Clinical evaluation by investigator at each scheduled visit. Confirmed by physical examination and documented photographically if applicable.
Time frame
From enrollment to the end of treatment at 12 monthsSecondary outcomes
1
Number of participants with investigator-confirmed new-onset ischemic rest pain or clinically confirmed ischemic foot ulcer at 12 months
Composite primary outcome defined as the number of participants who develop either: (1) new-onset ischemic rest pain confirmed by investigator clinical assessment, or (2) ischemic foot ulcer confirmed by physical examination with photographic documentation when applicable, by Month 12.
Time frame
From enrollment to the end of treatment at 12 months2
Number of participants with major adverse cardiovascular and cerebrovascular events (MACCE)
MACCE is defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
Time frame
From enrollment to the end of treatment at 12 months3
Number of participants hospitalized during the study
Number of participants who require inpatient hospitalization for any cause during the study period, as confirmed by hospital admission records or investigator documentation. Repeated hospitalizations in the same participant will be counted once unless otherwise specified in the statistical analysis plan.
Time frame
From enrollment to the end of treatment at 12 months4
Number of participants who die during the study
Number of participants who die from any cause during the study period, as confirmed by medical records, death certificates, hospital documentation, or investigator follow-up. Each participant will be counted once.
Time frame
From enrollment to the end of treatment at 12 monthsOther outcomes
1
Number of participants with clinically significant bleeding events
Number of participants with bleeding events during the study. Unit of Measure: Participants
Time frame
Baseline, Month 1, Month 3, Month 6, Month 12, and Month 182
Number of participants with clinically significant abnormal physical examination findings
Number of participants with clinically significant abnormal findings on physical examination.
Time frame
Baseline, Month 1, Month 3, Month 6, Month 12, and Month 183
Number of participants with clinically significant abnormal hematology test results
Number of participants with clinically significant abnormalities in hematology parameters, including white blood cell count, red blood cell count, hemoglobin, and platelet count.
Time frame
Baseline, Month 1, Month 3, Month 6, Month 12, and Month 184
Number of participants with clinically significant abnormal urinalysis results
Number of participants with clinically significant abnormalities in urinalysis parameters, including urine white blood cells, urine red blood cells, urine glucose, and urine protein.
Time frame
Baseline, Month 1, Month 3, Month 6, Month 12, and Month 18Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xuanwu Hospital, Beijing
Lead sponsor
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Collaborator
Dongzhimen Hospital, Beijing
Collaborator
Peking University Third Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: