Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency

A Comparative Study to Assess the Efficacy and Safety of Endolex Forte vs Diosmin and Hesperidin in Reducing the symptomatoLogy of Patients With ChronIc VeNous Insufficiency Between Functional Classes CEAP 1-4, During a Period of 6 Months

The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study.

A randomized, multicentered, open label, comparative study to assess the efficacy and safety of Endolex Forte® versus a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) in reducing the symptomatology of patients diagnosed with Chronic Venous Insufficiency which is rated between functional classes CEAP 1-4, during a period of 6 months.

Inclusion Criteria:

• Patients, male or females aged 18 to 75 years old
• BMI≤40
• Presence of chronic venous insufficiency which is rated between functional classes CEAP 1-4
• Patients diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.or patients presenting a painful venous symptomatology in the lower limbs for at least 30 days.
• Willing and able to give written informed consent prior to participation in the trial
• Patients expected to be compliant with the study treatment

Exclusion Criteria:

• Known allergy to the product's ingredients
• Pregnancy or breastfeeding
• Patient is involved in any other clinical trial
• Deep vein thrombosis
• Stasis dermatitis
• The patient is taking non-steroids anti-inflammatory drugs include oral , topical creams or patch form)
• Open ulcers or lower extremity amputation
• Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion
• Patient presenting permanent oedema,
• Patient with a history of lower limbs trauma responsible for sequel pains
• NYHA III and IV Heart Failure
• Renal Failure
• Untreated or uncontrolled Arterial Hypertension
• Hepatic Failure
• History of a known liver disease such as hepatitis A, hepatitis B, or C.
• Malignant neoplasms, from any etiology, or who are receiving any type of anticancer treatment, unless when properly treated and with no evidence of recurrence during the last five years
• Previous history of alcoholism, drug abuse, psychological or emotional problems in the last 5 years that can invalidate the Informed Consent Form or restrain participant's ability to comply with the requirements of the protocol.
• Immobility.