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

Phase 2

Completed

• Conditions: Raynaud Disease
• Interventions: Drug: Ginkgo biloba extract EGb 761

• Registration Number: NCT00251238
• Lead Sponsor: VSM Geneesmiddelen b.v.

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 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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-08
• Study First Submitted QC: 2005-11-08
• Study First Posted: 2005-11-09
• Primary Completion: 2006-03
• Study Completion: 2006-04
• Results First Submitted: 2015-01-12
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Results First Posted: 2017-05-22
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginkgo biloba extract EGb 761	Ginkgo biloba extract EGb 761	Receiving daily Ginkgo biloba extract EGb 761
Placebo	Ginkgo biloba extract EGb 761	Receiving daily placebo

Primary Outcome Measures

Name	Time	Method
Frequency of Vasospastic Attacks	Number of Vasospastic Attacks per day, for up to 10 weeks
Change From Baseline in Severity of Vasospastic Attacks	Baseline and 10 weeks	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.
Duration of Vasospastic Attacks	minutes per day

Trial Locations

Locations (1)

UMC ST Radboud; 🇳🇱 Nijmegen, Gelderland, Netherlands