Novel Treatment of Intermittent Claudication in Patients with Peripheral Arterial Disease Using Traditional Chinese Medicine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-14004215

Enrollment

Unknown

Registered

2014-01-28

Start date

2014-07-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication in Patients with Peripheral Arterial Disease

Interventions

Two groups:Intervention: Traditional Chinese Medicine Salviae miltiorrhizae (Danshen) and Puerariae lobatae (Gegen) versus placebo for 24 weeks

Eligibility

Sex/Gender

All

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 =10mmHg decrease in ankle artery blood pressure after exercise. In patients with non-compressible vessels (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 treadmill 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

Chinese University of Hong Kong

bryan.yan@cuhk.edu.hk+852 26323846

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026