NCT01532882

Efficacy and Safety of Diosmin 600mg Versus Placebo on Painful Symptomatology in Patients With Chronic Venous Disease of Lower Limbs

Assessment of the Efficacy and Safety of Diosmin 600mg on Painful Symptomatology in Patients With Chronic Venous Disease of Lower Limbs: a Multicentric, Randomised, Double-blind, Placebo-controlled Trial in Parallel Groups

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Laboratoire Innotech International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Diosmin has a well established use status in improvement of the symptoms of venolymphatic insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of capillary fragility. Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo, to establish its efficacy in the pain relief in Chronic Venous Disease (CVD). The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin 600 mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre, controlled, randomised, double blind, placebo-controlled, parallel-group study.

Conditions

• Chronic Venous Disease of Lower Limbs

Interventions

Type	Name	Description
DRUG	Diosmin	tablet, 600mg, PO, 1 tab per day during 28 days
DRUG	Placebo	tablet, PO, 1 per day during 28 days

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-03-01
• Completion: 2013-04-01
• First posted: 2012-02-15
• Last updated: 2013-04-29

Locations

1 site across 1 country: France