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Extract of Ginkgo Biloba (EGB 761) and Vascular Function Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Extract of Ginkgo Biloba (EGB 761) and Vascular Function conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Extract of Ginkgo Biloba (EGB 761) and Vascular Function Clinical research trials and Extract of Ginkgo Biloba (EGB 761) and Vascular Function healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Extract of Ginkgo Biloba (EGB 761) and Vascular Function. Extract of Ginkgo Biloba (EGB 761) and Vascular Function Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Extract of Ginkgo Biloba (EGB 761) and Vascular Function clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Extract of Ginkgo Biloba (EGB 761) and Vascular Function condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Extract of Ginkgo Biloba (EGB 761) and Vascular Function  Extract of Ginkgo Biloba (EGB 761) and Vascular Function
Extract of Ginkgo Biloba (EGB 761) and Vascular Function
For Condition: Peripheral Vascular Disease,Intermittent Claudication
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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.
Details: Objective: To 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. Background: 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. If these actions, or others, were discovered, then this herbal product could become used with greater confidence. Design: Randomized clinical trial, parallel design and double-blind. Four months of treatment with two treatment conditions: EGb 761 at 320 mg/day, compared to placebo. Populations: Adults over age 18 diagnosed with leg artery disease and pain on walking: 36 in each group. Outcomes: Improving walking distances of 30% or greater is the major goal. A second goal will test its safety 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. Implications: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 100
Location and Contact Information:
Stanford University *Recruiting*
Stanford, California, 94305
United States
Recruiting John Farquhar 650-723-6051
Additional Information:
Study ID Numbers: 1 R01 AT00204-02;
Study Start Date: September 2000
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029991
Other Peripheral Vascular Disease Studies:
1. Magnetic Resonance Imaging to Detect Blood Vessel Inflammation in Patients Undergoing Peripheral Balloon Angioplasty
2. Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP)
3. The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC
4. Extract of Ginkgo Biloba (EGB 761) and Vascular Function
5. A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia.
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Other Peripheral Vascular Disease Clinical Trials
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Extract of Ginkgo Biloba (EGB 761) and Vascular Function
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