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

Phase 2

Withdrawn

• Conditions: Venous Disease Classification (CEAP): C2 or C3
• Interventions: Drug: placebo CYCLO 3 ® FORT; Drug: MPFF; Drug: CYCLO 3 ® FORT; Drug: placebo MPFF

• Registration Number: NCT02907320
• Lead Sponsor: Pierre Fabre Medicament

Brief 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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Study Start: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo CYCLO 3 ® FORT	MPFF = Micronized Purified Flavonoid Fraction
placebo	placebo MPFF	MPFF = Micronized Purified Flavonoid Fraction
CYCLO 3 ® FORT and placebo MPFF	placebo MPFF	MPFF = Micronized Purified Flavonoid Fraction
MPFF and placebo CYCLO 3 ® FORT	MPFF	MPFF = Micronized Purified Flavonoid Fraction
MPFF and placebo CYCLO 3 ® FORT	placebo CYCLO 3 ® FORT	MPFF = Micronized Purified Flavonoid Fraction
CYCLO 3 ® FORT and placebo MPFF	CYCLO 3 ® FORT	MPFF = Micronized Purified Flavonoid Fraction

Primary Outcome Measures

Name	Time	Method
Change of Capillary diameter	From baseline (Day 0) to Day 56	Measure by microscan of capillary diameter, in micrometer on the worst leg (CEAP classification C2 or C3) at Baseline.

Secondary Outcome Measures

Name	Time	Method
Change of venoconstriction activity	From baseline (Day 0) to Day 56	Measure by Duplex-scan of vein diameter in millimeter on the worst leg (CEAP classification C2 or C3) at Baseline.