Venous Disease Classification (CEAP): C2 or C3 Clinical Trial
Official title:
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
| Verified date | February 2017 |
| Source | Pierre Fabre Medicament |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 .
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | May 2018 |
| Est. primary completion date | May 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: 1. Inclusion criteria - Non-menopausal women aged from 18 to 50 years - Symptomatic Primary chronic disorder C2 or C3 of advanced CEAP - Regular menstrual cycle - Use an efficient method of contraception - Having signed her written informed 2. Non-inclusion criteria 2.1 Related to pathology: - Superficial and or deep venous thrombosis - Venous insufficiency including history of deep venous thrombosis, post thrombotic syndrome, venous dysplasia, compressive syndrome - History of venous strapping or phlebotomy/ surgery of the evaluated leg - Sclerosing injection within 6 month before inclusion - Oedema from other etiology - Paresthesia, cramps of the lower limbs from other origin 2.2 Related to treatment: - Hypersensitivity, allergy or intolerance to study drugs - Iron storage disorder - Intake of venotonic treatment (oral or topic) ,triptan ,diuretics ,calcium blockers, beta blockers, ACE inhibitors, angiotensine II inhibitors, vasodilatators and/or vasoconstrictors within 1 month before inclusion - Intake of NSAID,corticosteroids,ergotamine, dihydroergotamine or any ergot alkaloids,vitamin C nutraceutical or phytotherapy products with potential venotonic effect within 2 weeks before inclusion 2.3 Related to the population: - History of diabetes - BMI= 30 - Grade V and VI on Fitzpatrick classification |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Pierre Fabre Medicament | Eurotrials Brasil Consultores Cientificos Ltda |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of Capillary diameter | Measure by microscan of capillary diameter, in micrometer on the worst leg (CEAP classification C2 or C3) at Baseline. | From baseline (Day 0) to Day 56 | |
| Secondary | Change of venoconstriction activity | Measure by Duplex-scan of vein diameter in millimeter on the worst leg (CEAP classification C2 or C3) at Baseline. | From baseline (Day 0) to Day 56 |