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

NCT02927483 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-10-28

No results posted yet for this study

Summary

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

Conditions

  • Chronic Venous Insufficiency

Interventions

DIETARY_SUPPLEMENT

Endolex Forte®

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

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • SunWave Pharma

    lead OTHER

Principal Investigators

  • Calin Giurcaneanu, MD · Spitalul Universitar de Urgenta Elias, Sectia Dermatologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-01-31
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02927483 on ClinicalTrials.gov