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Extract of Ginkgo Biloba (EGB 761) and Vascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00029991
Recruitment Status : Completed
First Posted : January 30, 2002
Last Update Posted : August 18, 2006
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Tracking Information
First Submitted Date  ICMJE January 29, 2002
First Posted Date  ICMJE January 30, 2002
Last Update Posted Date August 18, 2006
Study Start Date  ICMJE September 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
Maximal and pain-free walking distance
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
  • Flow mediated vasodilation of the brachial artery
  • Antibodies to epitopes of oxidized LDL
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extract of Ginkgo Biloba (EGB 761) and Vascular Function
Official Title  ICMJE Extract of Ginkgo Biloba (Egb 761) and Vascular Function
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.
Detailed Description

This study will determine if a highly standardized herbal extract of the leaves of the Ginkgo Biloba tree, widely used in Europe for two decades, will benefit patients who have pain on walking due to narrowing of the arteries of the legs. A few studies done about ten years ago in Germany appeared to benefit such patients. It is important to confirm these findings and to learn how it may work. Animal studies suggest that this extract, known as EGb 761, works through very strong antioxidant mechanisms. A second action suggested is that it stimulates cells lining the inside of the arteries to produce the compound nitric oxide. These cells, known as endothelial cells, are susceptible to damage by blood cholesterol, smoking or high blood pressure and, when damaged, will allow cholesterol to deposit in arteries. Antioxidants can prevent the endothelial cell damage, therefore it is very important to know if EGb 761 works through that mechanism. These cells also produce nitric oxide naturally as a defense against injury, so an EGb 761 effect on nitric oxide would also provide benefit. Consumption of Gingko Biloba products, many of uncertain purity, is increasing rapidly in the United States. Confirmation of its benefits, derived largely from Europe, is important to protect the health of the American people and to find new and inexpensive remedies for common problems, such as narrowed arteries in the legs. If benefit is found for this problem, then it will be highly likely that the atherosclerotic deposits that cause heart attacks and many strokes may also be preventable or treatable with this compound. Any benefit found will also lead to future studies to determine which constituents of the mixture now present in EGb 761 confers the benefit. If these actions, or others, were discovered, then this herbal product could become used with greater confidence.

This double-blind study will randomly assign parcicipants to receive 4 months of either EGb 761 at 320 mg/day or placebo. Improving walking distances by 30% or greater is the major goal. A second goal will test the safety of EGb 761 through careful examination of liver and kidney function and other measures of general health. Also, a thorough search will occur for antioxidant actions and for changes in endothelial cell nitric oxide production. Two study visits will occur at baseline, and two will occur at Month 4.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Intermittent Claudication
  • Peripheral Vascular Disease
Intervention  ICMJE Drug: Gingko Biloba (Herb)
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00029991
Other Study ID Numbers  ICMJE R01AT000204-02( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John W. Farquhar, MD Stanford University
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP