Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon

Raynaud Disease Clinical Trial

Official title:

Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251238
• Other study ID #: 523052.01.002
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2005
• Last updated: May 16, 2017
• Start date: November 2005
• Est. completion date: April 2006

Study information

• Verified date: May 2017
• Source: VSM Geneesmiddelen b.v.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Despite more than 150 years of research into the pathophysiology of Raynaud´s phenomenon it is still not understood sufficiently. Three mean mechanisms responsible for Raynaud´s 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 Raynaud´s 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 Raynaud´s phenomenon.

Aim: To determine the efficacy and safety of EGb 761® in patients with Raynaud´s phenomenon on the frequency, duration, and severity of vasospastic attacks compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Primary Raynaud´s phenomenon

• History of episodic digital or toe pallor

• Duration of Raynaud´s phenomenon at least 2 years

• Suffering form regular occuring attacks prior to enrolment

Exclusion Criteria:

• Secondary Raynaud´s phenomenon

• Connective tissue disease

• Large vessel disease

• Cryoglobulinemia, cold agglutinins disease, thrombocytosis

• Concomitant pharmacological treatment with effects on the vasculature

• Pregnancy or lactation

• Severe internal or systemic disease

Related Conditions & MeSH terms

• Raynaud Disease

Intervention

Drug:
• Ginkgo biloba extract EGb 761
daily Ginkgo biloba extract EGb 761

Locations

Country	Name	City	State
Netherlands	UMC ST Radboud	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
VSM Geneesmiddelen b.v.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Vasospastic Attacks		Number of Vasospastic Attacks per day, for up to 10 weeks
Primary	Duration of Vasospastic Attacks		minutes per day
Primary	Change From Baseline in Severity of Vasospastic Attacks	Severity of the complains due to Vasospastic Attacks was measured using a 10-steps likert scale.; The scale ranged between 0 and 10, with higher scores indicating more severe attacks.	Baseline and 10 weeks