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

SunWave Pharma

Status and phase: Unknown; Phase 3

Conditions: Chronic Venous Insufficiency

Treatments: Dietary Supplement: A combination of diosmin and hesperidin; Dietary Supplement: Endolex Forte®

Study type: Interventional

Funder types: Other

Identifiers

NCT02927483

OPSUN/0116/FS

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Endolex Forte®

Experimental group

Description:

Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.

Treatment:

Dietary Supplement: Endolex Forte®

A combination of diosmin and hesperidin

Active Comparator group

Description:

A combination of diosmin and hesperidin is a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) film-coated tablets administered from Baseline Visit until Day 180, two tablets per day.

Treatment:

Dietary Supplement: A combination of diosmin and hesperidin