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

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ClinicalTrials.gov Identifier: NCT02927483
Recruitment Status : Unknown
Verified October 2016 by SunWave Pharma.
Recruitment status was:  Not yet recruiting
First Posted : October 7, 2016
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Opera Contract Research Organization SRL
Information provided by (Responsible Party):
SunWave Pharma

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

Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Dietary Supplement: Endolex Forte® Dietary Supplement: A combination of diosmin and hesperidin Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Endolex Forte®
Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.
Dietary Supplement: Endolex Forte®
Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.

Active Comparator: A combination of diosmin and hesperidin
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
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.




Primary Outcome Measures :
  1. Change from baseline in limb volume determination at day 180 (water displacement method) [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Change from baseline in limb volume determination at day 90 (water displacement method) [ Time Frame: 90 days ]
  2. Change from pre-treatment (baseline) in the calf circumference on treatment day 30 [ Time Frame: 30 days ]
  3. Change from pre-treatment (baseline) in the calf circumference on treatment day 180 [ Time Frame: 180 days ]
  4. 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 [ Time Frame: 90 days ]
  5. 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 [ Time Frame: 180 days ]
  6. Global assessment of efficacy by the investigator at day 180 [ Time Frame: 180 days ]
  7. Questionnaire on improvement in symptoms at day 180 (CIVIQ-20) [ Time Frame: 180 days ]
  8. Global assessment of tolerability by the investigator at day 180 [ Time Frame: 180 days ]
  9. Adverse events [ Time Frame: 180 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927483


Contacts
Contact: Dionisio Barattini, MD +39 335 5437574 barattini@operacro.com
Contact: Serban Rosu, MD +40 722 313224 rosu@operacro.com

Sponsors and Collaborators
SunWave Pharma
Opera Contract Research Organization SRL
Investigators
Principal Investigator: Calin Giurcaneanu, MD Spitalul Universitar de Urgenta Elias, Sectia Dermatologie

Publications:
Responsible Party: SunWave Pharma
ClinicalTrials.gov Identifier: NCT02927483     History of Changes
Other Study ID Numbers: OPSUN/0116/FS
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by SunWave Pharma:
Venous Insufficiency

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases