This trial is active, not recruiting.

Condition raynaud disease
Treatment ginkgo biloba extract egb 761®
Phase phase 2
Sponsor VSM Geneesmiddelen b.v.
Start date November 2005
End date April 2006
Trial size 45 participants
Trial identifier NCT00251238, 523052.01.002


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose diagnostic

Primary Outcomes

Frequency of attacks
time frame:
Duration of attacks
time frame:
Severity of attacks
time frame:

Secondary Outcomes

Par- and dysesthesia of fingers or toes
time frame:
Coordination problems
time frame:
Interaction with daily activities
time frame:
Subjective assessment of colour anormalities of fingers
time frame:
Impact of attack trigger factors
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2006.
Information provided to ClinicalTrials.gov by VSM Geneesmiddelen b.v..