CCRB Logo

Trial History Detail on 2015-05-07

CUHK_CCT00392

2014-01-28

Prospective

CRE-2012.561-T

Health Medical Research Fund

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

N/A

Edwina So

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

26322931

edwinaso@cuhk.edu.hk

CUHK

Prof. Bryan Yan

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

26323878

bryan.yan@cuhk.edu.hk

CUHK

Novel Treatment of Intermittent Claudication in Patients with Peripheral Arterial Disease Using Danshen Gegen (D&G) Capsule

Novel Treatment of Intermittent Claudication in Patients with Peripheral Arterial Disease Using Danshen Gegen (D&G) Capsule

丹參葛根膠囊治療間隔性跛行伴外周動脈疾病的臨床研究

TCM study

Hong Kong

Yes

2013-07-04

Intermittent Claudication in Patients with Peripheral Arterial Disease

Drug

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

24 weeks

Placebo

1. Men and women 40 years or older
2. With stable intermittent claudication secondary to PAD defined as resting ABI <0.90 and a ≥10mmHg decrease in ankle artery blood pressure after exercise.
3. No change in existing therapy for claudication within 3 months of study enrollment.

1. Critical limb ischemia defined by ischemic rest pain, ulceration, or gangrene
2. Major lower limb amputation
3. Surgical or endovascular revascularization for PAD within 3 months prior to enrolment
4. Exercise limitation due to significant concomitant disease (e.g. severe arthritis, cardiac or pulmonary disease)
5. Pregnant women and women who are breastfeeding
6. Patients who are currently on Warfarin
7. Patients with resting systolic blood pressure below 100mmHg (SBP < 100mmHg)

40

N/A

Both Male and Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2015-05-04

226

Not Yet Recruiting

Primary efficacy measure: change in total distance walked from beginning treadmill 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

2015-05-07

ChiCTR-TRC-14004215

2014-01-28


Yes

Type Access Document Published On  
No documents yet.
  • Page 1 of 1.