Pharmacodynamic and clinical assessment of DC 982 GE (2,4 or 6 capsules per day) in patients with chronic venous disorders : randomised, placebo-controlled, dose effect, double blind, parallel group study

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 84

Inclusion Criteria

- Non-menopausal, non sterile women aged of more than 18 years,
- Primary chronic venous disorder (CVD)
Stage C1.2,S, or C2,S of the advanced CEAP clinical classification
Stable within the 6 months before the inclusion visit
Symptomatic at inclusion with a minimal score of 6 on VAS (0 to 10 cm) for at least one of the following symptoms :
-- Pain / heaviness
-- Paraesthesia/cramps
-- Feeling of swelling
- Incompetence of Great Saphenous Vein characterised by a reverse flow after calf compression release measured in the lower third of the thigh (7 cm to 13 cm upper the femorotibial joint space of the knee) longer or equal than 0.5 second with duplex scanning in standing position
- Agreeing not to use products with the same indication during the study,
- Agreeing to sign a written Informed Consent Form,
- Accepting to attend the planned visits at the investigational centre and to comply with all trial requirement,
- If required by national regulation, registered with a social security or health insurance system,
- For this woman of childbearing potential:
Regular menstrual cycle of 28 days ± 3,
Inclusion to be performed in the first period of the cycle (1st to 14th days)
Negative urine pregnancy test at inclusion,
Use an efficient method of contraception (implants, injectables, combined oral contraceptives, some intra-uterine devices) for at least 2 months before the study, during the study and one month after the end of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Related to the pathology
- Superficial and or deep venous thrombosis detected with the duplex scan
- Secondary venous insufficiency including :
a.history of deep venous thrombosis,
b.post thrombotic syndrome,
c.venous dysplasia,
d.compressive syndrome
- Primary venous reflux of deep veins,
- History of venous stripping or phlebectomy
- Any sclerosing injections within the 6 months before the inclusion,
- Oedema from any aetiology including : chronic heart failure, liver disease, renal disease, lymphatic pathology (Stemmer sign), iatrogenic (calcium blockers ...)...,
- Paresthesia of the lower limbs from other origin,
- Any pain of the lower limbs in relationship with another pathology (e.g. arthrosis, neuropathy, peripheral vascular disease ...).
- Acute or chronic systemic disease or disorder liable to interfere with study implementation and/or study parameter assessment

Related to treatments
- Hypersensitivity, allergy or intolerance to Ruscus extract, Hesperidin Methyl Chalcone , Ascorbic Acid, sunset yellow (E110) or any component of the formulation,
- Intake of venotonic treatments, triptans, diuretics, calcium blockers, beta blockers, ACE inhibitors, and/or vasodilators and/or vasoconstrictors, within the month before the inclusion visit,
- NSAID, corticosteroids, ergotamine, dihydroergotamine or any ergot alkaloids, vitamin C, nutraceutical or phytotherapy products with potential venotonic effect intake within the 2 weeks before the inclusion visit
- Bandages or compression within the 2 weeks before the inclusion visit.

Related to the population
- BMI superior or equal to 30
- Underlying arteriopathy
- History of pulmonary embolism
- Medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, puts them at risk or is likely to modify their handling of the study drug,
- Female who is pregnant or breast feeding or not using contraception, or planning to become pregnant,
- Participation to an other clinical trial in the previous month or during the study,
- Patient who, is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent,
- Patient who, in the judgement of the investigator, is not likely to be compliant during the study,
- Patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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