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Trial History Detail on 2015-06-10

CUHK_CCT00317

2012-04-23

Prospective

None

Pending

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

N/A

Edwina So

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

(852)26322931

edwinaso@cuhk.edu.hk

CUHK

Prof. Bryan Yan

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

(852)26323846

bryan.yan@cuhk.edu.hk

CUHK

A Novel Pharmacological Treatment of Intermittent Claudication in Patients with Peripheral Arterial Disease: A Randomized Double-blind Placebo-control Trial of Traditional Chinese Medicine Salviae miltiorhizae(Danshen) and Puerariae lobatae (Gegen)

A Novel Pharmacological Treatment of Intermittent Claudication in Patients with Peripheral Arterial Disease: A Randomized Double-blind Placebo-control Trial of Traditional Chinese Medicine Salviae miltiorhizae(Danshen) and Puerariae lobatae (Gegen)

TCM study

Hong Kong

Yes

2012-03-27

Intermittent Claudication in Patients with Peripheral Arterial Disease

Other

pri

Traditional Chinese Medicine Salviae miltiorrhizae (Danshen) and Puerariae lobatae (Gegen)

24 weeks

Placebo

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 <0.90 in at least 1 limb and a ≥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

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

40

N/A

Both Male and Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2012-04-23

272

Unknown

Primary efficacy measure: change in total distance walked from beginning treadmil walking until the subject can walk no further

Secondary efficacy endpoints: 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

No

2015-06-10

ChiCTR-TRC-12002137

2012-05-01


Yes

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