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
NCT ID: NCT02907320
Last Updated: 2017-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-12-31
2018-05-31
Brief Summary
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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 .
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CYCLO 3 ® FORT and placebo MPFF
MPFF = Micronized Purified Flavonoid Fraction
CYCLO 3 ® FORT
placebo MPFF
MPFF and placebo CYCLO 3 ® FORT
MPFF = Micronized Purified Flavonoid Fraction
MPFF
placebo CYCLO 3 ® FORT
placebo
MPFF = Micronized Purified Flavonoid Fraction
placebo CYCLO 3 ® FORT
placebo MPFF
Interventions
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CYCLO 3 ® FORT
MPFF
placebo CYCLO 3 ® FORT
placebo MPFF
Eligibility Criteria
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Inclusion Criteria
* Symptomatic Primary chronic disorder C2 or C3 of advanced CEAP
* Regular menstrual cycle
* Use an efficient method of contraception
* Having signed her written informed
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Eurotrials Brasil Consultores Cientificos Ltda
INDUSTRY
Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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Zahida Issiakhem Belkaid, MD
Role: STUDY_DIRECTOR
Pierre Fabre Medicament
Other Identifiers
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DC0982 GE 2 04
Identifier Type: -
Identifier Source: org_study_id
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