Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029991
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-01-29
Brief Title:
Extract of Ginkgo Biloba EGB 761 and Vascular Function
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Extract of Ginkgo Biloba Egb 761 and Vascular Function
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday 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
This double-blind study will randomly assign parcicipants to receive 4 months of either EGb 761 at 320 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None