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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change of Capillary diameter
研究概览
简要总结
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Grade V and VI on Fitzpatrick classification
排除标准
- 未提供
研究组 & 干预措施
CYCLO 3 ® FORT and placebo MPFF
MPFF = Micronized Purified Flavonoid Fraction
干预措施: placebo MPFF (Drug)
CYCLO 3 ® FORT and placebo MPFF
MPFF = Micronized Purified Flavonoid Fraction
干预措施: CYCLO 3 ® FORT (Drug)
MPFF and placebo CYCLO 3 ® FORT
MPFF = Micronized Purified Flavonoid Fraction
干预措施: MPFF (Drug)
MPFF and placebo CYCLO 3 ® FORT
MPFF = Micronized Purified Flavonoid Fraction
干预措施: placebo CYCLO 3 ® FORT (Drug)
placebo
MPFF = Micronized Purified Flavonoid Fraction
干预措施: placebo CYCLO 3 ® FORT (Drug)
placebo
MPFF = Micronized Purified Flavonoid Fraction
干预措施: placebo MPFF (Drug)
结局指标
主要结局
Change of Capillary diameter
时间窗: 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.
次要结局
- Change of venoconstriction activity(From baseline (Day 0) to Day 56)