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

Study Overview
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Brief Summary
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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 .

Official Title
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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

Conditions
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Venous Disease Classification (CEAP): C2 or C3

Intervention / Treatment
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* Drug: CYCLO 3 ® FORT
* Drug: MPFF
* Drug: placebo CYCLO 3 ® FORT
* Drug: placebo MPFF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CYCLO 3 ® FORT and placebo MPFF<br>MPFF = Micronized Purified Flavonoid Fraction | Drug: CYCLO 3 ® FORT<br> <br> Drug: placebo MPFF<br> <br> |
| Active Comparator: MPFF and placebo CYCLO 3 ® FORT<br>MPFF = Micronized Purified Flavonoid Fraction | Drug: MPFF<br> <br> Drug: placebo CYCLO 3 ® FORT<br> <br> |
| Placebo Comparator: placebo<br>MPFF = Micronized Purified Flavonoid Fraction | Drug: placebo CYCLO 3 ® FORT<br> <br> Drug: placebo MPFF<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |