NCT02927483

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: SunWave Pharma · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-01-01
• Completion: 2017-06-01
• First posted: 2016-10-07
• Last updated: 2016-10-28