Phase 2 N=41 Randomized Quadruple-blind Diagnostic

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

Raynaud Disease

Bottom Line

View on ClinicalTrials.gov: NCT00251238 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Frequency of Vasospastic Attacks — 2.4; 2.0 attacks per day

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ginkgo biloba extract EGb 761 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VSM Geneesmiddelen b.v.
Primary completion: Mar 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Vasospastic Attacks	2.4; 2.0	—
PRIMARY Duration of Vasospastic Attacks	47.4; 50.9	—
PRIMARY Change From Baseline in Severity of Vasospastic Attacks	-1.3; -1.3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00251238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.