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

Last updated: October 27, 2016
Sponsor: SunWave Pharma
Overall Status: Trial Status Unknown

Phase

3

Condition

Venous Thrombosis

Deep Vein Thrombosis

Varicose Veins

Treatment

N/A

Clinical Study ID

NCT02927483
OPSUN/0116/FS
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients, male or females aged 18 to 75 years old

  • BMI≤40

  • Presence of chronic venous insufficiency which is rated between functional classesCEAP 1-4

  • Patients diagnosed with superficial vein thrombophlebitis and have skin reaction byredness, swelling, fever and pain symptoms.or patients presenting a painful venoussymptomatology 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

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 , topicalcreams or patch form)

  • Open ulcers or lower extremity amputation

  • Patient treated by venotonic treatments or vascular protectants or assimilated dietarysupplements 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 anticancertreatment, unless when properly treated and with no evidence of recurrence during thelast five years

  • Previous history of alcoholism, drug abuse, psychological or emotional problems in thelast 5 years that can invalidate the Informed Consent Form or restrain participant'sability to comply with the requirements of the protocol.

  • Immobility.

Study Design

Total Participants: 120
Study Start date:
November 01, 2016
Estimated Completion Date:
June 30, 2017

Study 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.