Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251238
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2005-11-08
Brief Title:
Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynauds Phenomenon
Sponsor:
VSM Geneesmiddelen bv
Organization:
VSM Geneesmiddelen bv
Study Overview
Official Title:
Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761 in Patients With Raynauds Phenomenon
Status:
COMPLETED
Status Verified Date:
2017-05
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:
The aim of the study is to investigate the efficacy and safety of EGb 761 in patients with the primary Raynaud phenomenon with regards to the frequency duration and severity of vasospastic attacks
Detailed Description:
Despite more than 150 years of research into the pathophysiology of Raynauds phenomenon it is still not understood sufficiently Three mean mechanisms responsible for Raynauds phenomenon are discussed and fall into the following three categories
neurological malfunction
pathological blood vessel wall and blood cell interactions
inflammatory and immunological responses Based on these concepts different classes of drugs have been tested Although some therapies have shown effects prolongation of the therapy is often difficult due to side-effects
Considering a prevalence of 5-10 in the general population there is still a place and probably a need for the development of new treatment concepts Ginkgo biloba has shown to have anti-oxidative and anti-platelet activities In a small placebo controlled trial in patients with the Raynauds phenomenon promising results for the Ginkgo biloba extract were shown EGb 761 is known to be safe and well tolerated Based on the above considerations EGb 761 may be an effective treatment for Raynauds phenomenon
Aim To determine the efficacy and safety of EGb 761 in patients with Raynauds phenomenon on the frequency duration and severity of vasospastic attacks compared to placebo
neurological malfunction
pathological blood vessel wall and blood cell interactions
inflammatory and immunological responses Based on these concepts different classes of drugs have been tested Although some therapies have shown effects prolongation of the therapy is often difficult due to side-effects
Considering a prevalence of 5-10 in the general population there is still a place and probably a need for the development of new treatment concepts Ginkgo biloba has shown to have anti-oxidative and anti-platelet activities In a small placebo controlled trial in patients with the Raynauds phenomenon promising results for the Ginkgo biloba extract were shown EGb 761 is known to be safe and well tolerated Based on the above considerations EGb 761 may be an effective treatment for Raynauds phenomenon
Aim To determine the efficacy and safety of EGb 761 in patients with Raynauds phenomenon on the frequency duration and severity of vasospastic attacks compared to placebo
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