Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029679
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-01-18
Brief Title:
Borage Oil and Ginkgo Biloba EGb 761 in Asthma
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Borage Oil and Ginkgo Biloba EGb 761 in Asthma
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess clinical efficacy andor adverse effects of dietary borage oil which contains gamma-linolenic acid GLA and Ginkgo biloba in patients with mild persistent to moderate asthma
Detailed Description:
The concept of asthma as a condition in which acute and chronic inflammatory changes in airways play a fundamental role is well established The role of leukotrienes as a crucial element of these inflammatory processes is supported by abundant laboratory and clinical evidence There is a potential for herbal medicinal approaches to ameliorate leukotriene-mediated inflammation in asthma based on data from the literature and our laboratory Studies suggest that dietary GLA found in borage and evening primrose oils is unique among the n-6 polyunsaturated fatty acid family members linolenic acid GLA and arachidonic acid in its potential to attenuate inflammatory processes For instance there are randomized placebo-controlled trials RCT demonstrating efficacy of dietary GLA in treating patients with rheumatoid arthritis and active synovitis Ginkgo biloba a flavonoid-rich extract of leaves of the Ginkgo biloba tree has been studied in one RCT with asthma patients and is recommended by complementary and alternative practitioners as treatment for allergic inflammation and asthma Ginkgo biloba supplements have no known adverse effects
We will assess clinical efficacies andor adverse effects of dietary borage oil and Ginkgo biloba in patients with asthma in a 17 month RCT We also propose to delineate whether or not the clinical course of treatment correlates with suppression of leukotriene B4 LTB4 LTC4 and LTD4 generated by activated polymorphonuclear cells Additionally in the Ginkgo biloba arms of study the in vitroex vivo inhibition of histamine release will be assayed since one of its major constituents quercetin is known to be structurally related to cromolyn sodium and has been shown in vitro studies to exhibit similar activities Furthermore anti-inflammatory activities of Ginkgo biloba will be compared to those of some of its individual constituents in a series of in vitro experiments It is hoped that findings from these studies will evolve relatively non-toxic therapeutic alternatives for attenuating bronchial hyperresponsiveness and inflammation in patients with asthma
We will assess clinical efficacies andor adverse effects of dietary borage oil and Ginkgo biloba in patients with asthma in a 17 month RCT We also propose to delineate whether or not the clinical course of treatment correlates with suppression of leukotriene B4 LTB4 LTC4 and LTD4 generated by activated polymorphonuclear cells Additionally in the Ginkgo biloba arms of study the in vitroex vivo inhibition of histamine release will be assayed since one of its major constituents quercetin is known to be structurally related to cromolyn sodium and has been shown in vitro studies to exhibit similar activities Furthermore anti-inflammatory activities of Ginkgo biloba will be compared to those of some of its individual constituents in a series of in vitro experiments It is hoped that findings from these studies will evolve relatively non-toxic therapeutic alternatives for attenuating bronchial hyperresponsiveness and inflammation in patients with asthma
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