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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Venous Insufficiency

Intervention / Treatment
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* Dietary Supplement: Endolex Forte®
* Dietary Supplement: A combination of diosmin and hesperidin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endolex Forte®<br>Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day. | Dietary Supplement: Endolex Forte®<br>* Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.<br>|
| Active Comparator: A combination of diosmin and hesperidin<br>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. | Dietary Supplement: A combination of diosmin and hesperidin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in limb volume determination at day 180 (water displacement method) |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in limb volume determination at day 90 (water displacement method) |  | 90 days | 
| Change from pre-treatment (baseline) in the calf circumference on treatment day 30 |  | 30 days | 
| Change from pre-treatment (baseline) in the calf circumference on treatment day 180 |  | 180 days | 
| Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 90 |  | 90 days | 
| Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 180 |  | 180 days | 
| Global assessment of efficacy by the investigator at day 180 |  | 180 days | 
| Questionnaire on improvement in symptoms at day 180 (CIVIQ-20) |  | 180 days | 
| Global assessment of tolerability by the investigator at day 180 |  | 180 days | 
| Adverse events |  | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Insufficiency