Extract of Ginkgo Biloba (EGB 761) and Vascular Function

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine if a highly standardized herbal extract of the leaves of the Ginkgo Biloba tree will benefit patients who have pain on walking due to narrowing of the arteries of the legs.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

• Males and non-pregnant females.

• Intermittent claudication or rest pain due to peripheral arterial disease, in a steady clinical state for at least three months according to physician's opinion. The peripheral arterial disease must be confirmed by Doppler ankle brachial index (ABI).

• Wash-out of disallowed medications of at least four weeks prior to screening.

• Patient understands all elements of informed consent and has agreed to it in writing prior to enrollment.

Exclusion Criteria

• Peripheral arterial disease of non-atherosclerotic nature.

• Inability to walk at least 50 feet on a standardized treadmill.

• Any type of major surgery during the last three months and, in particular, aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 months; leg amputation above the ankle.

• Any disease process, other than PAD, limiting exercise capacity on the treadmill.

• Myocardial infarction in the previous 3 months.

• Current enrollment in another clinical trial and/or ingestion of another investigational product within the past 30 days.

• Diabetes retinopathy, age-related maculopathy, or any other proliferative retinopathy.

• Active malignant disease or history of malignancy.

• Intolerance to sublingual nitroglycerin.

• Uncontrolled hypertension.

• Type I diabetes.

• Use of pentoxifylline, carnitine, arginine or prostacyclin.

• Use of antioxidants other than those in the usual multivitamin mixture.