Extract of Ginkgo Biloba (EGB 761) and Vascular Function

NCT00029991 | Completed Phase 1

• 1 other identifier: R01AT000204-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intermittent Claudication; Peripheral Vascular Disease

Keywords

Leg pain; Peripheral angiopathies; Vascular Diseases, peripheral

Outcome Measures

Primary Outcomes (1)

• Maximal and pain-free walking distance

Secondary Outcomes (2)

• Flow mediated vasodilation of the brachial artery

• Antibodies to epitopes of oxidized LDL

Interventions

Gingko Biloba (Herb) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• Gardner CD, Taylor-Piliae RE, Kiazand A, Nicholus J, Rigby AJ, Farquhar JW. Effect of Ginkgo biloba (EGb 761) on treadmill walking time among adults with peripheral artery disease: a randomized clinical trial. J Cardiopulm Rehabil Prev. 2008 Jul-Aug;28(4):258-65. doi: 10.1097/01.HCR.0000327184.51992.b8.

  PMID: 18628657 DERIVED

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Vascular Diseases

Interventions

Ginkgo Extract

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• John W. Farquhar, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 29, 2002
• First Posted: January 30, 2002
• Study Start: September 1, 2000
• Study Completion: July 1, 2005
• Last Updated: August 18, 2006

Record last verified: 2006-07

Locations

US (1)