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

• Status: Completed
• Trial end date: 2017-06-02
• Target enrollment: 0
• Participant gender: All

Summary

Peripheral arterial disease (PAD) due to lower limb arterial blockages affects significant proportion of the population with an age-adjusted prevalence of approximately 12%. Claudication induced walking impairment can be debilitating and adversely affects social, leisure, and occupational activities in many patients and is associated with higher mortality among PAD patients.

Unfortunately, very few effective therapies are available to improve leg symptoms and exercise performance in PAD patients. Surgery is the last resort but results vary. Therefore, there is a large unmet need for medical therapies that can improve long-term walking performance and functional capacity in PAD patients.

Danshen and Gegen (D&G) are commonly used Chinese herbal medicine in the treatment of cardiovascular diseases. D&G study has been extensively researched and continued at The Chinese University of Hong Kong (CUHK) for their antioxidative and vasodilator properties, modulate anti-atherosclerosis and improve arthrogenic athophysiology. Three randomized trials were completed at the CUHK showing D&G improved lipid profile, vascular function and thinned down the internal layer of the carotid artery. One may expect the same with lower limb arteries. Extensive clinical experiences of use in China and Hong Kong indicated that D&G are well tolerated and safe.

This project is a randomized control trial to determine the efficacy and Safety of D&G in improving the functional capacity & QoL in patients with symptomatic PAD. The results of this study have the potential to change local and international practice in providing a much needed therapeutic option in the treatment of PAD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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)