NCT02907320

EXPLORATORY ASSESSMENT OF THE EFFECTS OF CYCLO 3 ® FORT (Ruscus Extract, Hesperidin Methyl Chalcone, Ascorbic Acid) OR MICRONISED PURIFIED FLAVONOID FRACTION ON VASCULAR PARAMETERS AND BIOMARKERS IN WOMEN SUFFERING FROM CHRONIC VENOUS DISEASE (CEAP C2 OR C3), OVER 8 WEEKS

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Chronic Venous Disorder is the most prevalent vascular disease. It is multifactorial pathology that has an important impact on quality of life and represents a significant public health concern, due to its very high frequency in all European and American (north and south) countries. Venous pathology develops when venous pressure is increased and return of blood is impaired through several mechanisms. Wish induce leg symptoms (tingling, aching, burning, pain, muscle cramps, sensation of swelling, sensations of throbbing or heaviness, itching skin, restless legs, leg tiredness and/or fatigue. The aims of this research is to study the effects on microcirculatory activity (activity on very small vessels) of CYCLO 3 ® FORT, MPFF (Micronised Purified Flavonoid Fraction) and Placebo after 8 week of treatment by Microscan, and Duplex, two imaging non-invasive technologies will be performed to obtain measurements of microcirculatory parameters in standardized and reproducible conditions for all the participants. In addition, will assess, in blood samples, the inflammatory biomarkers .

Conditions

• Venous Disease Classification (CEAP): C2 or C3

Interventions

Type	Name	Description
DRUG	CYCLO 3 ® FORT
DRUG	MPFF
DRUG	placebo CYCLO 3 ® FORT
DRUG	placebo MPFF

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2016-09-20
• Last updated: 2017-02-20