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:
Participant gender:
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.