Peripheral Arterial Disease
Conditions
Interventions
Two groups:Traditional Chinese Medicine Salviae miltiorrhizae (Danshen) and Puerariae lobatae (Gegen) vs Placebo for 24 weeks
Sponsors
Department of Medicine & Therapeutics, The Chinese University of Hong Kong
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Men and women 40 years or older - At least 3-month history of stable IC (Rutherford class 2 or 3) secondary to lower extremity PAD - PAD defined as resting ABI 1.50), the toe–brachial index (TBI) at rest has to be <0.70 - Reproducible walking distances with <25% variance between 2 baseline treadmill tests and who terminated all screening treadmill tests solely because of IC pain
Exclusion criteria
Exclusion criteria: Critical limb ischemia defined by ischemic rest pain, ulceration, or gangrene (Rutherford class =4) - Major lower limb amputation (above or below knee amputation) - Surgical or endovascular revascularization for PAD within 3 months - Exercise limitation due to significant concomitant disease (e.g. severe hip or knee arthritis, coronary artery disease, heart failure, chronic obstructive airway disease) - Concomitant anticoagulation therapy (e.g. warfarin) - Pregnancy or breastfeeding - Unable to complete the screening and follow-up treadmill protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in total distance walked from beginning treadmil walking until the subject can walk no further; | — |
Secondary
| Measure | Time frame |
|---|---|
| change in distance walked at the onset of claudication, QoL, Functional status, ABI before and after exercise, combined cardiovascular events including vascular death, myocardial infarction, stroke, revascularization or readmission to hospital for a vascular or atherosclerosis-related complication; | — |
Countries
China
Contacts
Public ContactProf. Bryan Yan
Outcome results
None listed